The goals of this study are to learn: - If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated - If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away
This study will consist of two parts. Part 1 will assess the safety, tolerability, and efficacy of gocatamig and I-DXd at doses determined in study MK-6070-001 (NCT: NCT04471727). Part 2 will assess the safety and tolerability of gocatamig in participants in Japan and China. Part 3 will assess the safety, tolerability, and efficacy of gocatamig with durvalumab.
Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. ClinicalTrials.gov to learn more about this study. 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 (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and or suspected ILD/pneumonitis Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
Protocol Number: 25-0794
More information available at ClinicalTrials.gov: NCT06780137
Principal Investigator