First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
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| ClinicalTrials.gov Identifier: NCT05361395 |
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Recruitment Status :
Recruiting
First Posted : May 4, 2022
Last Update Posted : April 12, 2024
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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Brief Summary:
This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Extensive Stage Small Cell Lung Cancer | Drug: Tarlatamab Drug: Carboplatin Drug: Etoposide Drug: Atezolizumab Drug: Durvalumab | Phase 1 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 340 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer |
| Actual Study Start Date : | August 24, 2022 |
| Estimated Primary Completion Date : | December 30, 2025 |
| Estimated Study Completion Date : | January 1, 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part 1: Dose Exploration Combination Regimen 1
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
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Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757 Drug: Carboplatin Carboplatin will be administered as an intravenous (IV) infusion. Drug: Etoposide Etoposide will be administered as an intravenous (IV) infusion. Drug: Atezolizumab Atezolizumab will be administered as an intravenous (IV) infusion.
Other Name: Tecentriq |
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Experimental: Part 2: Dose Exploration Combination Regimen 2
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
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Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757 Drug: Carboplatin Carboplatin will be administered as an intravenous (IV) infusion. Drug: Etoposide Etoposide will be administered as an intravenous (IV) infusion. Drug: Atezolizumab Atezolizumab will be administered as an intravenous (IV) infusion.
Other Name: Tecentriq |
|
Experimental: Part 3: Dose Exploration Combination Regimen 3
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
|
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757 Drug: Carboplatin Carboplatin will be administered as an intravenous (IV) infusion. Drug: Etoposide Etoposide will be administered as an intravenous (IV) infusion. Drug: Atezolizumab Atezolizumab will be administered as an intravenous (IV) infusion.
Other Name: Tecentriq |
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Experimental: Part 4: Dose Expansion
Expansion of Part 1, Part 2, or Part 3 with Atezolizumab
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Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757 Drug: Carboplatin Carboplatin will be administered as an intravenous (IV) infusion. Drug: Etoposide Etoposide will be administered as an intravenous (IV) infusion. Drug: Atezolizumab Atezolizumab will be administered as an intravenous (IV) infusion.
Other Name: Tecentriq |
|
Experimental: Part 5: Dose Exploration Maintenance
Tarlatamab+Atezolizumab
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Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757 Drug: Atezolizumab Atezolizumab will be administered as an intravenous (IV) infusion.
Other Name: Tecentriq |
|
Experimental: Part 6: Dose Expansion Maintenance
Expansion of Part 5 with Atezolizumab
|
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757 Drug: Atezolizumab Atezolizumab will be administered as an intravenous (IV) infusion.
Other Name: Tecentriq |
|
Experimental: Part 7: Dose Expansion
Expansion of Part 1, 2, or 3 with Durvalumab
|
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757 Drug: Carboplatin Carboplatin will be administered as an intravenous (IV) infusion. Drug: Etoposide Etoposide will be administered as an intravenous (IV) infusion. Drug: Durvalumab Durvalumab will be administered as an intravenous (IV) infusion. |
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Experimental: Part 8: Dose Expansion Maintenance
Expansion of Part 5 with Durvalumab
|
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757 Drug: Durvalumab Durvalumab will be administered as an intravenous (IV) infusion. |
|
Experimental: Part 9: Dose Expansion Maintenance
Expansion with Tarlatamab+Durvalumab
|
Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Name: AMG 757 Drug: Durvalumab Durvalumab will be administered as an intravenous (IV) infusion. |
Primary Outcome Measures :
- Number of Participants with a Dose Limiting Toxicity (DLT) [ Time Frame: 24 months ]
- Number of Participants with Treatment-emergent Adverse Events (TEAE) [ Time Frame: 24 months ]
- Number of Participants with Treatment-related Adverse Events [ Time Frame: 24 months ]
- Number of Participants with Clinically Significant Changes in Vital Signs [ Time Frame: 24 months ]
- Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements [ Time Frame: 24 months ]
- Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests [ Time Frame: 24 months ]
Secondary Outcome Measures :
- 6-month Progression-free Survival (PFS) [ Time Frame: 24 months ]
- Objective Response (OR) [ Time Frame: 24 months ]Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Duration of Response (DOR) [ Time Frame: 24 months ]
- Disease Control Rate(DCR) [ Time Frame: 24 months ]
- Overall Survival (OS) [ Time Frame: 24 months ]
- Serum Concentration of Tarlatamab [ Time Frame: 24 months ]
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Age greater than or equal to 18 years old at the same time of signing the informed consent.
- Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.
- Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
- Eastern Cooperative Oncology Group (ECOG) 0 to 1.
- Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria.
- Adequate organ function as defined in protocol.
Exclusion Criteria:
- History of other malignancy within the past 2 years with exceptions.
- Major surgery within 28 days of study day 1.
- Untreated or symptomatic brain metastases and leptomeningeal disease.
- Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
- History of immune-related colitis.
- History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment
- Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint
- NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to an active treatment and after consultation with Medical Monitor. Participants requiring oral antibiotics who have been afebrile for >24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required.
- History of hypophysitis or pituitary dysfunction.
- History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.
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): NCT05361395
Contacts
| Contact: Amgen Call Center | 866-572-6436 | medinfo@amgen.com |
Locations
Show 44 study locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
Additional Information:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT05361395 |
| Other Study ID Numbers: |
20200469 2021-005462-17 ( EudraCT Number ) |
| First Posted: | May 4, 2022 Key Record Dates |
| Last Update Posted: | April 12, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Time Frame: | Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study. |
| Access Criteria: | Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below. |
| URL: | http://www.amgen.com/datasharing |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Amgen:
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Extensive Stage Small Cell Lung Cancer ES-SCLC SCLC Lung Cancer AMG 757 Bi-Specific T-Cell Engager |
BiTE Inmunotherapy Immunooncology Inmuno-oncology DLL3 Delta Like Protein 3 |
Additional relevant MeSH terms:
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Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Carboplatin Etoposide |
Atezolizumab Durvalumab AMG 757 Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immune Checkpoint Inhibitors Antineoplastic Agents, Immunological |