Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)

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ClinicalTrials.gov Identifier: NCT05298423

Recruitment Status : Recruiting

First Posted : March 28, 2022

Last Update Posted : April 25, 2024

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Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme LLC

Study Description

Brief Summary:

This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following:

progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants.
overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants.

Condition or disease	Intervention/treatment	Phase
Carcinoma, Non-Small-Cell Lung	Biological: pembrolizumab/vibostolimab Biological: durvalumab Drug: cisplatin Drug: pemetrexed Drug: etoposide Drug: carboplatin Drug: paclitaxel Radiation: thoracic radiotherapy	Phase 3

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	784 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC
Actual Study Start Date :	May 3, 2022
Estimated Primary Completion Date :	September 1, 2028
Estimated Study Completion Date :	September 4, 2029

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Lung cancer

Drug Information available for: Pembrolizumab Durvalumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy For the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray [Gy] in 2 Gy fractions for 30 days total) during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to ~14 months). Cycles 1-20 are 21-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.	Biological: pembrolizumab/vibostolimab Administered as an intravenous (IV) infusion Other Name: MK-7684A Drug: cisplatin Administered as an IV infusion Other Name: PLATINOL-AQ® Drug: pemetrexed Administered as an IV infusion Other Name: ALIMTA® Drug: etoposide Administered as an IV infusion Other Name: TOPOSAR® Drug: carboplatin Administered as an IV infusion Other Name: PARAPLATIN® Drug: paclitaxel Administered as an IV infusion Other Name: TAXOL® Radiation: thoracic radiotherapy Administered as an external beam radiation
Active Comparator: chemotherapy+radiotherapy+durvalumab For the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy in 2 Gy fractions for 30 days total) during Cycles 2 and 3. Following cCRT, participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.	Biological: durvalumab Administered as an IV infusion Other Name: IMFINZI® Drug: cisplatin Administered as an IV infusion Other Name: PLATINOL-AQ® Drug: pemetrexed Administered as an IV infusion Other Name: ALIMTA® Drug: etoposide Administered as an IV infusion Other Name: TOPOSAR® Drug: carboplatin Administered as an IV infusion Other Name: PARAPLATIN® Drug: paclitaxel Administered as an IV infusion Other Name: TAXOL® Radiation: thoracic radiotherapy Administered as an external beam radiation

Arm

Intervention/treatment

Experimental: pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy

For the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray [Gy] in 2 Gy fractions for 30 days total) during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to ~14 months). Cycles 1-20 are 21-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.

Biological: pembrolizumab/vibostolimab

Administered as an intravenous (IV) infusion

Other Name: MK-7684A

Drug: cisplatin

Administered as an IV infusion

Other Name: PLATINOL-AQ®

Drug: pemetrexed

Administered as an IV infusion

Other Name: ALIMTA®

Drug: etoposide

Administered as an IV infusion

Other Name: TOPOSAR®

Drug: carboplatin

Administered as an IV infusion

Other Name: PARAPLATIN®

Drug: paclitaxel

Administered as an IV infusion

Other Name: TAXOL®

Radiation: thoracic radiotherapy

Administered as an external beam radiation

Active Comparator: chemotherapy+radiotherapy+durvalumab

For the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy in 2 Gy fractions for 30 days total) during Cycles 2 and 3. Following cCRT, participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles.

Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.

Biological: durvalumab

Administered as an IV infusion

Other Name: IMFINZI®

Drug: cisplatin

Administered as an IV infusion

Other Name: PLATINOL-AQ®

Drug: pemetrexed

Administered as an IV infusion

Other Name: ALIMTA®

Drug: etoposide

Administered as an IV infusion

Other Name: TOPOSAR®

Drug: carboplatin

Administered as an IV infusion

Other Name: PARAPLATIN®

Drug: paclitaxel

Administered as an IV infusion

Other Name: TAXOL®

Radiation: thoracic radiotherapy

Administered as an external beam radiation

Outcome Measures

Primary Outcome Measures :

Progression-Free Survival (PFS) For All Participants [ Time Frame: Up to approximately 55 months ]
PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Progression-Free Survival (PFS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% [ Time Frame: Up to approximately 55 months ]
PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Overall Survival (OS) For All Participants [ Time Frame: Up to approximately 75 months ]
OS is defined as the time from randomization to death due to any cause.
Overall Survival (OS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% [ Time Frame: Up to approximately 75 months ]
OS is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures :

Objective Response Rate (ORR) For All Participants [ Time Frame: Up to approximately 75 months ]
ORR is defined as the percentage of participants who have a best response of confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).
Objective Response Rate (ORR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% [ Time Frame: Up to approximately 75 months ]
ORR is defined as the percentage of participants who have a best response of confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).
Number of Participants Who Experience at Least One Adverse Event (AE) [ Time Frame: Up to approximately 75 months ]
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) [ Time Frame: Up to approximately 75 months ]
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Duration of Response (DOR) For All Participants [ Time Frame: Up to approximately 75 months ]
Duration of Response (DOR) is the time from first documented evidence of Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Duration of Response (DOR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% [ Time Frame: Up to approximately 75 months ]
Duration of Response (DOR) is the time from first documented evidence of Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).
Change from Baseline in the Global Health Status /Quality of Life Items 29 and 30 Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) For All Participants [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Change from Baseline in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) For All Participants [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.
Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1% [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1% [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% [ Time Frame: Baseline (at randomization) and at the end of study (approximately 75 months post randomization) ]
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For All Participants [ Time Frame: Up to approximately 75 months post randomization ]
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% [ Time Frame: Up to approximately 75 months post randomization ]
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall QoL during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants [ Time Frame: Up to approximately 75 months post randomization ]
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% [ Time Frame: Up to approximately 75 months post randomization ]
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For All Participants [ Time Frame: Up to approximately 75 months post randomization ]
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1% [ Time Frame: Up to approximately 75 months post randomization ]
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants [ Time Frame: Up to approximately 75 months post randomization ]
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1% [ Time Frame: Up to approximately 75 months post randomization ]
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants [ Time Frame: Up to approximately 75 months post randomization ]
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1% [ Time Frame: Up to approximately 75 months post randomization ]
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of ≥10-point deterioration (out of 100) from baseline and confirmed by a second adjacent ≥10-point deterioration from baseline.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria

Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.
Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain
Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review
Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLC
Has provided tumor tissue sample (tissue biopsy [core, incisional, or excisional])
Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
Has a life expectancy of at least 6 months

Exclusion Criteria

Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible
Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
Has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention
Is expected to require any other form of antineoplastic therapy, while on study
Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection
Has had an allogenic tissue/solid organ transplant

Pemetrexed-specific Criteria:

Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed
Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05298423

Contacts

Layout table for location contacts

Contact: Toll Free Number	1-888-577-8839	Trialsites@merck.com

Locations

Show 142 study locations

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United States, California
VA Long Beach Healthcare System ( Site 2831)	Recruiting
Long Beach, California, United States, 90822
Contact: Study Coordinator 562-826-8000
VA West Los Angeles Medical Center ( Site 2808)	Recruiting
Los Angeles, California, United States, 90073
Contact: Study Coordinator 310-478-3711
United States, Florida
Millennium Oncology Research Clinic ( Site 2801)	Recruiting
Hollywood, Florida, United States, 33024
Contact: Study Coordinator 954-450-1808
Mid Florida Hematology and Oncology Center ( Site 2800)	Recruiting
Orange City, Florida, United States, 32763
Contact: Study Coordinator 386-774-1223
United States, Illinois
University of Chicago Medical Center ( Site 2828)	Recruiting
Chicago, Illinois, United States, 60637
Contact: Study Coordinator 855-702-8222
United States, Indiana
Franciscan St. Francis Health ( Site 2812)	Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Study Coordinator 317-528-7060
United States, Maryland
MFSMC-HJWCI ( Site 2804)	Recruiting
Baltimore, Maryland, United States, 21237
Contact: Study Coordinator 443-777-7147
United States, Massachusetts
Boston Medical Center ( Site 2829)	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Study Coordinator 617-638-8265
University of Massachusetts Chan Medical School ( Site 2815)	Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Study Coordinator 508-334-1000
United States, Missouri
Cox Medical Center North-Cox Medical Center/Hulston Cancer Center/ Radiation Oncology ( Site 2837)	Recruiting
Springfield, Missouri, United States, 65807
Contact: Study Coordinator 417-269-6115
United States, New Jersey
Rutgers Cancer Institute of New Jersey ( Site 2805)	Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Study Coordinator 732-235-2465
United States, New York
Icahn School of Medicine at Mount Sinai ( Site 2821)	Recruiting
New York, New York, United States, 10029
Contact: Study Coordinator 443-570-5327
White Plains Hospital ( Site 2835)	Recruiting
White Plains, New York, United States, 10601
Contact: Study Coordinator 914-849-7630
United States, Oregon
Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 2816)	Recruiting
Portland, Oregon, United States, 97227
Contact: Study Coordinator 503-335-2400
United States, Pennsylvania
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 2827)	Recruiting
Lancaster, Pennsylvania, United States, 17601
Contact: Study Coordinator 717-544-9400
Thomas Jefferson University - Clinical Research Institute ( Site 2813)	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Study Coordinator 215-955-8874
United States, Texas
Millennium Research & Clinical Development ( Site 2811)	Recruiting
Houston, Texas, United States, 77090
Contact: Study Coordinator 281-440-5006
Central Texas Veterans health care-Oncology & Hematology ( Site 2819)	Completed
Temple, Texas, United States, 76504
United States, Washington
MultiCare Health System ( Site 2817)	Recruiting
Tacoma, Washington, United States, 98405
Contact: Study Coordinator 253-403-6177
Australia, Australian Capital Territory
Canberra Hospital ( Site 0010)	Recruiting
Canberra, Australian Capital Territory, Australia, 2605
Contact: Study Coordinator 610251242220
Australia, Tasmania
Icon Cancer Centre Hobart ( Site 0003)	Recruiting
Hobart, Tasmania, Australia, 7000
Contact: Study Coordinator 0437636224
Australia, Victoria
Ballarat Health Services-Medical Oncology ( Site 0002)	Recruiting
Ballarat Central, Victoria, Australia, 3350
Contact: Study Coordinator 0413578465
Frankston Hospital-Oncology and Haematology ( Site 0009)	Recruiting
Frankston, Victoria, Australia, 3199
Contact: Study Coordinator (03) 9784 7071
St Vincent's Hospital-Oncology Clinical Trials ( Site 0005)	Recruiting
Melbourne, Victoria, Australia, 3065
Contact: Study Coordinator 61392313167
Brazil
Hospital Nossa Senhora da Conceição ( Site 0111)	Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
Contact: Study Coordinator +5551993590437
Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0105)	Recruiting
Rio de Janeiro, Brazil, 22793-080
Contact: Study Coordinator +55212399-0212
A. C. Camargo Cancer Center-CAPEC ( Site 0102)	Recruiting
Sao Paulo, Brazil, 01509-010
Contact: Study Coordinator +551121895021
Chile
James Lind Centro de Investigación del Cáncer ( Site 0202)	Recruiting
Temuco, Araucania, Chile, 4800827
Contact: Study Coordinator +56452982404
Biocenter ( Site 0208)	Recruiting
Concepción, Biobio, Chile, 4070196
Contact: Study Coordinator +56974779078
FALP-UIDO ( Site 0205)	Recruiting
Santiago, Region M. De Santiago, Chile, 7500921
Contact: Study Coordinator +56981369487
Centro de Oncología de Precisión ( Site 0209)	Recruiting
Santiago, Region M. De Santiago, Chile, 7560908
Contact: Study Coordinator +56991612199
Bradfordhill ( Site 0200)	Recruiting
Santiago, Region M. De Santiago, Chile, 8420383
Contact: Study Coordinator +56998744662
ONCOCENTRO APYS-ACEREY ( Site 0203)	Recruiting
Viña del Mar, Valparaiso, Chile, 2520598
Contact: Study Coordinator +56322323980
China, Beijing
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 0328)	Recruiting
Beijing, Beijing, China, 100142
Contact: Study Coordinator 010-88196479
Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 0309)	Recruiting
Beijing, Beijing, China, 100142
Contact: Study Coordinator 010-88196948
Beijing Peking Union Medical College Hospital-pneumology department ( Site 0300)	Recruiting
Beijing, Beijing, China, 100730
Contact: Study Coordinator 13911235467
China, Chongqing
Army Medical Center of People's Liberation Army-Oncology Department ( Site 0321)	Recruiting
Chongqing, Chongqing, China, 400042
Contact: Study Coordinator 18580408265
China, Fujian
Fujian Medical University Union Hospital-1 Bingfanglou ( Site 0330)	Recruiting
Fuzhou Fujian, Fujian, China, 350001
Contact: Study Coordinator +86 0591 86218325
Fujian Provincial Cancer Hospital ( Site 0316)	Recruiting
Fuzhou, Fujian, China, 350014
Contact: Study Coordinator +86 0591-62752500
The First Affiliated hospital of Xiamen University-oncology ( Site 0317)	Recruiting
Xiamen, Fujian, China, 361003
Contact: Study Coordinator +86 0592-2132222
China, Guangdong
Southern Medical University Nanfang Hospital-Department of Oncology ( Site 0336)	Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Study Coordinator 020-62787730
China, Hebei
Fourth Hospital of Hebei Medical University ( Site 0331)	Recruiting
Shijiazhuang, Hebei, China, 050035
Contact: Study Coordinator 13931182128
China, Henan
Henan Cancer Hospital ( Site 0333)	Recruiting
Zhengzhou, Henan, China, 450008
Contact: Study Coordinator 13607695140
China, Hubei
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0315)	Recruiting
Wuhan, Hubei, China, 430022
Contact: Study Coordinator +86 027-85726300
Hubei Cancer Hospital ( Site 0311)	Recruiting
Wuhan, Hubei, China, 430079
Contact: Study Coordinator +86 027-87670318
China, Hunan
Xiangya Hospital Central South University-Oncology department ( Site 0310)	Recruiting
Changsha, Hunan, China, 410008
Contact: Study Coordinator 13875898127
Hunan Cancer Hospital ( Site 0307)	Recruiting
Changsha, Hunan, China, 410013
Contact: Study Coordinator 0731-89762231
China, Jiangsu
The Second Affiliated Hospital of Soochow University ( Site 0314)	Recruiting
Suzhou, Jiangsu, China, 215004
Contact: Study Coordinator +86 13951106391
Affiliated Hospital of Jiangsu University ( Site 0305)	Recruiting
Zhenjiang, Jiangsu, China, 212000
Contact: Study Coordinator 8613952850016
China, Jilin
Jilin Cancer Hospital-oncology department ( Site 0319)	Recruiting
Changchun, Jilin, China, 132000
Contact: Study Coordinator 0431-80596065
China, Shandong
Shandong Provincial Hospital ( Site 0326)	Recruiting
Jinan, Shandong, China, 250001
Contact: Study Coordinator 15168888787
Qingdao Central Hospital-Endocrinology ( Site 0332)	Recruiting
Qingdao, Shandong, China, 266042
Contact: Study Coordinator +86-18660229210
China, Shanghai
Shanghai Chest Hospital-Radiotherapy Department ( Site 0306)	Recruiting
Shanghai, Shanghai, China, 200030
Contact: Study Coordinator 13651635103
Fudan University Shanghai Cancer Center ( Site 0304)	Recruiting
Shanghai, Shanghai, China, 200032
Contact: Study Coordinator 021-64175590
Shanghai Pulmonary Hospital-Radiotherapy department ( Site 0335)	Recruiting
Shanghai, Shanghai, China, 200433
Contact: Study Coordinator +86 13817025327
China, Shanxi
Shanxi Cancer Hospital-Pulmonology ( Site 0322)	Recruiting
Taiyuan, Shanxi, China, 030000
Contact: Study Coordinator 18635169066
China, Sichuan
West China Hospital of Sichuan University ( Site 0324)	Recruiting
Cheng Du, Sichuan, China
Contact: Study Coordinator 18980601766
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital-radiotherapy ( Site 0329)	Recruiting
Tianjin, Tianjin, China, 300060
Contact: Study Coordinator 022-23524155
China, Zhejiang
Hangzhou Cancer Hospital-Medical Oncology ( Site 0302)	Recruiting
Hangzhou, Zhejiang, China, 310002
Contact: Study Coordinator 18857110928
The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0301)	Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Study Coordinator 13868071869
Zhejiang Cancer Hospital ( Site 0308)	Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Study Coordinator 13858037993
Costa Rica
CIMCA ( Site 0501)	Recruiting
San José, San Jose, Costa Rica, 10103
Contact: Study Coordinator +50683893636
PROCLINICAL Pharma ( Site 0504)	Recruiting
San José, San Jose, Costa Rica, 11303
Contact: Study Coordinator 50683778387
Hospital Metropolitano - Sede Lindora ( Site 0503)	Recruiting
Santa Ana, San Jose, Costa Rica, 10903
Contact: Study Coordinator +5064035 1212
Dominican Republic
Instituto de Oncologia ( Site 3003)	Recruiting
Santo Domingo, Distrito Nacional, Dominican Republic, 10102
Contact: Study Coordinator +18099615245
Onconet ( Site 3002)	Recruiting
Distrito Nacional, Santo Domingo, Dominican Republic, 10148
Contact: Study Coordinator +18098611000
Germany
Klinikum Chemnitz-Klinik für Innere Medizin IV ( Site 0607)	Recruiting
Chemnitz, Sachsen, Germany, 09116
Contact: Study Coordinator +4937133343072
LungenClinic Grosshansdorf-Onkologie ( Site 0602)	Recruiting
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Contact: Study Coordinator +4941026012101
Universitaetsklinikum Schleswig-Holstein Campus Kiel-Medizinische Klinik II, Hämatologie und Onkolo	Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Study Coordinator +4943150022563
Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 0603	Recruiting
Berlin, Germany, 13353
Contact: Study Coordinator +4930450665005
Greece
Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 0703)	Recruiting
Athens, Attiki, Greece, 115 26
Contact: Study Coordinator 00302106972246
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0706)	Recruiting
Athens, Attiki, Greece, 115 28
Contact: Study Coordinator 00306946462998
Sotiria Thoracic Diseases Hospital of Athens ( Site 0704)	Recruiting
Athens, Attiki, Greece, 11527
Contact: Study Coordinator +302107700220
Metropolitan Hospital ( Site 0702)	Recruiting
Athens, Attiki, Greece, 185 47
Contact: Study Coordinator 00302104809339
General Oncology Hospital of Kifissia "Agioi Anargiroi"-2nd Department of Medical Oncology ( Site 07	Recruiting
Nea Kifissia, Attiki, Greece, 136 77
Contact: Study Coordinator 00302103501711
University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0700)	Recruiting
Heraklion, Irakleio, Greece, 715 00
Contact: Study Coordinator 00302810392783
European Interbalkan Medical Center ( Site 0701)	Recruiting
Thessaloniki, Greece, 57001
Contact: Study Coordinator 00302310400368
Guatemala
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0802)	Recruiting
Ciudad de Guatemala, Guatemala, 01010
Contact: Study Coordinator +502 30635474
Centro Regional de Sub Especialidades Médicas SA ( Site 0801)	Recruiting
Quetzaltenango, Guatemala, 09001
Contact: Study Coordinator +502 59450559
Centro Medico Integral De Cancerología (CEMIC) ( Site 0805)	Recruiting
Quetzaltenango, Guatemala, 09002
Contact: Study Coordinator +502 59458053
Israel
Rambam Health Care Campus-Oncology ( Site 1001)	Recruiting
Haifa, Israel, 3109601
Contact: Study Coordinator 972-4-7776412
Shaare Zedek Medical Center ( Site 1003)	Recruiting
Jerusalem, Israel, 9103102
Contact: Study Coordinator +972587040620
Rabin Medical Center ( Site 1004)	Recruiting
Petah Tikva, Israel, 4941 492
Contact: Study Coordinator + 9729378101
Sheba Medical Center-ONCOLOGY ( Site 1000)	Recruiting
Ramat Gan, Israel, 5265601
Contact: Study Coordinator 97235307096
Sourasky Medical Center ( Site 1002)	Recruiting
Tel Aviv, Israel, 6423906
Contact: Study Coordinator +972 36973494
Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia medica Toraco-Polmonare ( Site 1107)	Recruiting
Napoli, Campania, Italy, 80131
Contact: Study Coordinator 390817770291
Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 1101)	Recruiting
Roma, Lazio, Italy, 00128
Contact: Study Coordinator 3906225418020
Ospedale San Raffaele ( Site 1104)	Recruiting
Milano, Lombardia, Italy, 20132
Contact: Study Coordinator 390226436627
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1100)	Recruiting
Milan, Lombardia, Italy, 20133
Contact: Study Coordinator 390223905000
Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1102)	Recruiting
Monza, Lombardia, Italy, 20900
Contact: Study Coordinator 390392339678
Fondazione IRCCS Policlinico San Matteo ( Site 1103)	Recruiting
Pavia, Lombardia, Italy, 27100
Contact: Study Coordinator +390382503132
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1105)	Recruiting
Brescia, Italy, 25123
Contact: Study Coordinator +390303995271
Japan
National Hospital Organization Shikoku Cancer Center ( Site 1211)	Recruiting
Matsuyama, Ehime, Japan, 791-0280
Contact: Study Coordinator +81-89-999-1111
Kurume University Hospital ( Site 1212)	Recruiting
Kurume, Fukuoka, Japan, 830-0011
Contact: Study Coordinator +81-942-35-3311
Kobe Minimally Invasive Cancer Center ( Site 1210)	Recruiting
Kobe, Hyogo, Japan, 650-0046
Contact: Study Coordinator +81-78-304-4100
Kanagawa cancer center ( Site 1204)	Recruiting
Yokohama, Kanagawa, Japan, 241-8515
Contact: Study Coordinator +81-45-520-2222
Miyagi Cancer Center ( Site 1200)	Recruiting
Natori, Miyagi, Japan, 981-1293
Contact: Study Coordinator +81-22-384-3151
Sendai Kousei Hospital ( Site 1213)	Recruiting
Sendai, Miyagi, Japan, 981-0914
Contact: Study Coordinator +81-22-222-6181
Niigata Cancer Center Hospital ( Site 1205)	Recruiting
Niigata-shi, Niigata, Japan, 951-8566
Contact: Study Coordinator +81-25-266-5111
Kansai Medical University Hospital ( Site 1207)	Recruiting
Hirakata, Osaka, Japan, 573-1191
Contact: Study Coordinator +81-72-804-0101
Osaka Medical and Pharmaceutical University Hospital ( Site 1208)	Recruiting
Takatsuki, Osaka, Japan, 569-8686
Contact: Study Coordinator +81-72-683-1221
Saitama Prefectural Cancer Center ( Site 1201)	Recruiting
Ina-machi, Saitama, Japan, 362-0806
Contact: Study Coordinator +81-48-722-1111
Japanese Foundation for Cancer Research ( Site 1202)	Recruiting
Koto, Tokyo, Japan, 135-8550
Contact: Study Coordinator +81-3-3520-0111
Showa University Hospital ( Site 1203)	Recruiting
Shinagawa, Tokyo, Japan, 142-8666
Contact: Study Coordinator +81-3-3784-8000
Osaka International Cancer Institute ( Site 1209)	Recruiting
Osaka, Japan, 541-8567
Contact: Study Coordinator +81-6-6945-1181
Korea, Republic of
Chungbuk National University Hospital-Internal medicine ( Site 2400)	Recruiting
Cheongju-si, Chungbuk, Korea, Republic of, 28644
Contact: Study Coordinator 82432696898
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2401)	Recruiting
Suwon-si, Kyonggi-do, Korea, Republic of, 16247
Contact: Study Coordinator 82312498485
Ajou University Hospital-Hematology-Oncology ( Site 2402)	Recruiting
Suwon-si, Kyonggi-do, Korea, Republic of, 16499
Contact: Study Coordinator 820312194266
Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 2403)	Recruiting
Seoul, Korea, Republic of, 03722
Contact: Study Coordinator 820222280880
Malaysia
University Malaya Medical Centre-Clinical Oncology ( Site 1402)	Recruiting
Lembah Pantai, Kuala Lumpur, Malaysia, 59100
Contact: Study Coordinator +6013-5121839
Hospital Pulau Pinang ( Site 1400)	Recruiting
George Town, Pulau Pinang, Malaysia, 10990
Contact: Study Coordinator +604-2225767
Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1401)	Recruiting
Kuala Lumpur, Malaysia, 50586
Contact: Study Coordinator +6017233-6295
Mexico
Arké SMO S.A. de C.V. ( Site 1504)	Recruiting
Mexico, Distrito Federal, Mexico, 06700
Contact: Study Coordinator 55 55115833
Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 1505)	Recruiting
Guadalajara, Jalisco, Mexico, 44680
Contact: Study Coordinator +52 (33) 1639-5372
Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 1507)	Recruiting
Chihuahua, Mexico, 31217
Contact: Study Coordinator +52 (614) 180-3800
Centro de Investigacion Clinica de Oaxaca ( Site 1501)	Recruiting
Oaxaca, Mexico, 68020
Contact: Study Coordinator 9516035559
Portugal
Hospital CUF Descobertas ( Site 2006)	Recruiting
Lisbon, Lisboa, Portugal, 1998-018
Contact: Study Coordinator +351210025200
Centro Hospitalar do Porto - Hospital de Santo António ( Site 2004)	Recruiting
Porto, Portugal, 4099-001
Contact: Study Coordinator +351222077500
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2001)	Recruiting
Porto, Portugal, 4200-072
Contact: Study Coordinator +351225084000
Romania
Centrul Medical Medicover Victoria ( Site 2106)	Recruiting
Bucharest, Bucuresti, Romania, 010626
Contact: Study Coordinator +40737877881
Amethyst Radiotherapy Center ( Site 2102)	Recruiting
Florești, Cluj, Romania, 407280
Contact: Study Coordinator 40742206212
Centrul de Oncologie "Sfântul Nectarie" ( Site 2100)	Recruiting
Craiova, Dolj, Romania, 200542
Contact: Study Coordinator 40727774974
Radiology Therapeutic Center ( Site 2108)	Recruiting
Otopeni, Ilfov, Romania, 075100
Contact: Study Coordinator 40723171603
Cabinet Medical Oncomed ( Site 2101)	Recruiting
Timișoara, Timis, Romania, 300239
Contact: Study Coordinator 0040745100495
South Africa
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2304)	Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6055
Contact: Study Coordinator 27413630581
Wilgers Oncology Centre ( Site 2301)	Recruiting
Pretoria, Gauteng, South Africa, 0040
Contact: Study Coordinator +27128072744
The Oncology Centre ( Site 2300)	Recruiting
Durban, Kwazulu-Natal, South Africa, 4091
Contact: Study Coordinator +27312088666
Abraham Oncology ( Site 2303)	Recruiting
Richards Bay, Kwazulu-Natal, South Africa, 3900
Contact: Study Coordinator 0357800247
Cape Town Oncology Trials ( Site 2306)	Recruiting
Cape Town, Western Cape, South Africa, 7570
Contact: Study Coordinator 27219443832
Spain
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit	Recruiting
Barcelona, Cataluna, Spain, 08036
Contact: Study Coordinator +34932275402
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2502)	Recruiting
Santiago de Compostela, La Coruna, Spain, 15706
Contact: Study Coordinator 981950511
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2504)	Recruiting
Pozuelo de Alarcon, Madrid, Comunidad De, Spain, 28223
Contact: Study Coordinator 0034914521987
Hospital Universitari Vall d'Hebron ( Site 2501)	Recruiting
Barcelona, Spain, 08035
Contact: Study Coordinator +34932746085
Turkey
Medipol Mega Universite Hastanesi-oncology ( Site 2611)	Recruiting
Stanbul, Istanbul, Turkey, 34214
Contact: Study Coordinator +905325280486
Ege University Medicine of Faculty-Chest Diseases Department ( Site 2603)	Recruiting
Bornova, Izmir, Turkey, 35100
Contact: Study Coordinator +902323434343
I.E.U. Medical Point Hastanesi-Oncology ( Site 2612)	Recruiting
Izmir, Karsiyaka, Izmir, Turkey, 009035575
Contact: Study Coordinator +905052642353
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2607)	Recruiting
Adana, Turkey, 01250
Contact: Study Coordinator 03223444444
Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 2602)	Recruiting
Ankara, Turkey, 06010
Contact: Study Coordinator (0312) 042000
Hacettepe Universitesi-oncology hospital ( Site 2605)	Recruiting
Ankara, Turkey, 06230
Contact: Study Coordinator +903123053432
Memorial Ankara Hastanesi-Medical Oncology ( Site 2609)	Recruiting
Ankara, Turkey, 06520
Contact: Study Coordinator +903122536666
Ankara City Hospital-Medical Oncology ( Site 2601)	Recruiting
Ankara, Turkey, 06800
Contact: Study Coordinator +903125526000
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2610)	Recruiting
Istanbul, Turkey, 34722
Contact: Study Coordinator 00902162803333

Sponsors and Collaborators

Merck Sharp & Dohme LLC

Investigators

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Study Director:	Medical Director	Merck Sharp & Dohme LLC

More Information

Additional Information:

Merck Clinical Trials Information This link exits the ClinicalTrials.gov site

Plain Language Summary This link exits the ClinicalTrials.gov site

Layout table for additonal information

Responsible Party:	Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:	NCT05298423
Other Study ID Numbers:	7684A-006 MK-7684A-006 ( Other Identifier: Merck ) KEYVIBE-006 ( Other Identifier: Merck ) jRCT2021220015 ( Registry Identifier: jRCT ) PHRR230831-006071 ( Registry Identifier: PHRR ) 2021-005135-23 ( EudraCT Number )
First Posted:	March 28, 2022 Key Record Dates
Last Update Posted:	April 25, 2024
Last Verified:	April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL:	http://engagezone.msd.com/ds_documentation.php

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Merck Sharp & Dohme LLC:


Programmed Cell Death-1 (PD1, PD-1) Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)

Additional relevant MeSH terms:

Layout table for MeSH terms

Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Paclitaxel Etoposide Carboplatin Pembrolizumab Pemetrexed	Durvalumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

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