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Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients (NEOpredict)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04205552
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Essen

Study Description
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Brief Summary:
The primary objective of this study is to determine the feasibility of four weeks of preoperative immunotherapy with Nivolumab, and Nivolumab plus Relatlimab in patients with early stage or locally advanced non-small cell lung cancer eligible for curative resection.

Condition or disease Intervention/treatment Phase
NSCLC Stage II NSCLC, Stage IIIA NSCLC, Stage I Drug: Nivolumab 10 MG/ML Intravenous Solution Drug: Relatlimab 10 MG/ML Intravenous Solution Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients: Defining Optimal Combinations and Determinants of Immunological Response
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab

Nivolumab 2 cycles, every two weeks (q2w)

o Nivolumab 240 mg i.v. over 30 min

 Drug: Nivolumab 10 MG/ML Intravenous Solution
Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min
Experimental: Nivolumab/Relatlimab (80 mg)

Nivolumab/Relatlimab (80 mg) 2 cycles, every two weeks (q2w)

  • Nivolumab 240 mg i.v. over 30 min
  • Relatlimab 80 mg i.v. over 30 min (within 30 min of nivolumab)
 Drug: Nivolumab 10 MG/ML Intravenous Solution
Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min

Drug: Relatlimab 10 MG/ML Intravenous Solution
Neoadjuvant 2 cycles, every two weeks (q2w) Relatlimab 80 mg i.v. over 30 min
Experimental: Nivolumab/Relatlimab (240 mg)

Nivolumab/Relatlimab (240 mg) 2 cycles, every two weeks (q2w)

  • Nivolumab 240 mg i.v. over 30 min
  • Relatlimab 240 mg i.v. over 30 min (within 30 min of nivolumab)
 Drug: Nivolumab 10 MG/ML Intravenous Solution
Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min

Drug: Relatlimab 10 MG/ML Intravenous Solution
Neoadjuvant 2 cycles, every two weeks (q2w) Relatlimab 80 mg i.v. over 30 min


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of four weeks of preoperative immunotherapy with Nivolumab, Nivolumab plus Relatlimab (80 mg), and Nivolumab plus Relatlimab (240 mg) [ Time Frame: Within 43 days after first study medication ]

Secondary Outcome Measures :
  1. Estimation of pathological tumor response rate [ Time Frame: Within 43 days after first study medication (day of surgery) ]
  2. Estimation of curative (R0) resection rate [ Time Frame: Within 43 days after first study medication (day of surgery) ]
  3. Objective radiological response rate [ Time Frame: After 3, 6, 9 and 12 months post-surgery ]
    Objective radiological response rate per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

  4. Disease-free survival rate at 12 months [ Time Frame: 12 months ]
    Assessment of disease-free survival rate at 12 months per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

  5. Overall survival rate at 12 months [ Time Frame: 12 months ]
  6. Morbidity [ Time Frame: within 90 days after surgery ]
    Estimation of morbidity within 90 days after surgery

  7. Mortality [ Time Frame: within 90 days after surgery ]
    Estimation of mortality within 90 days after surgery


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

Inclusion Criteria:

  • Patients with histologically confirmed non-small cell lung cancer (NSCLC) eligible for anatomic resection (Clinical stages I B, II and selected stage III A)
  • Eastern Cooperative Oncology Group (ECOG) ≤ 1
  • Sufficient pulmonary function to undergo curative lung cancer surgery
  • Adequate hematological, hepatic and renal function parameters:
  • Sufficient cardiac left ventricular defined as left ventricular ejection fraction (LVEF) ≥ 50% documented either by echocardiography or multigated acquisition scan (MUGA)
  • Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures

Exclusion Criteria:

  • Active or history of autoimmune disease or immune deficiency
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
  • Subjects who have undergone organ transplant or allogeneic stem cell transplantation
  • Uncontrolled or significant cardiovascular disease
  • Patients with active neurological disease
  • Active malignancy or a prior malignancy within the past 3 years
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of study medication
  • Peripheral polyneuropathy NCI CTCAE Grade ≥ 2
  • History of gastric perforation or fistulae in past 6 months
  • Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to enrollment.
  • The patient has undergone major surgery within 28 days prior to enrollment except staging mediastinoscopy, diagnostic Video Assisted Thoracoscopic Surgery (VATS) or implantation of a venous port-system.
  • Any other concurrent preoperative antineoplastic treatment including irradiation
  • Pregnant/Breastfeeding women
  • Subjects with history of severe toxicity or life-threatening toxicity (grade 3 or 4) related to prior immune therapy
  • Prior treatment with Lymphocyte-activation gene 3 (LAG-3) targeting Agent
  • Previous treatment with Nivolumab or Relatlimab
Contacts and Locations
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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): NCT04205552


Contacts
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Contact: Chiara Nicolini, PhD 0049 201 723 44708 chiara.nicolini@uk-essen.de

Locations
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Belgium
Jessa Hospital Hasselt Recruiting
Hasselt, Belgium
Germany
University Hospital Essen Recruiting
Essen, Germany
Thoraxklinik Heidelberg gGmbH-Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69126
Netherlands
Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands
Sponsors and Collaborators
University Hospital, Essen
Investigators
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Principal Investigator: Martin Schuler, Prof. Dr. University Hospital, Essen
More Information
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Responsible Party: University Hospital, Essen
ClinicalTrials.gov Identifier: NCT04205552    
Other Study ID Numbers: CA224-063
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Nivolumab
Relatlimab
Pharmaceutical Solutions
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action