A Phase 1b/2 Study Evaluating MK-6070 and Ifinatamab Deruxtecan (MK-2400) Regimens as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are investigating new treatments for extensive-stage small cell lung cancer (ES-SCLC), a type of lung cancer that has spread widely within or beyond the lungs. The study aims to evaluate the safety and effectiveness of combining two study drugs, gocatamig and ifinatamab deruxtecan (I-DXd), alongside standard treatments. These medicines include a T-cell engager therapy and an antibody drug conjugate, both designed to target and destroy cancer cells by boosting the immune response or delivering treatment directly to cancer cells. Participants are assigned to different treatment groups based on prior therapies and disease status. Some receive gocatamig and I-DXd as maintenance treatment after standard chemotherapy and immunotherapy, while others receive these drugs during both induction and maintenance phases. Additional groups receive combinations including gocatamig with atezolizumab or standard chemotherapy drugs carboplatin, etoposide, and atezolizumab. Treatments are given intravenously until disease progression or other criteria for stopping treatment are met. During the study, participants will undergo regular evaluations to monitor safety, side effects, and treatment response, including imaging to assess tumor size and laboratory tests to measure drug levels. Researchers will track adverse events, dose-limiting toxicities, and discontinuations due to side effects over up to approximately 58 months. They will also measure objective response rates and other survival outcomes. Participants may receive supportive medications as needed, and the study includes ongoing monitoring to gather detailed information about the treatments' effects over time.

A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)