A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)
A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC + Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 44 months
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Time frame: Up to approximately 3 weeks
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 44 months
Part 1: Objective Response Rate (ORR)
Time frame: Up to approximately 44 months
Secondary Endpoints
Part 1, Part 2 (Arm 5, Arm 6, and Arm 8), and Part 3 (Arm 7): Duration of Response (DOR)
Part 1, Part 2 (Arm 6 and Arm 8), and Part 3 (Arm 7): Progression-Free Survival (PFS)
Part 2 (Arm 5, Arm 6, and Arm 8) and Part 3 (Arm 7): ORR
Eligibility Criteria
Inclusion Criteria: * Has histologically or cytologically confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy * Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample * Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART) Exclusion Criteria: * Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure * History of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use or has current or suspected pneumonitis/ILD that cannot be ruled out by imaging at screening * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART * History within 6 months before the first dose of …
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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