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A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body. A standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy. * Chemotherapy is a treatment that works to destroy cancer cells or stop them from growing. * Immunotherapy is a treatment that helps the immune system fight cancer. Gocatamig and I-DXd (short for ifinatamab deruxtecan) are study medicines. Researchers want to know if giving gocatamig and I-DXd together can treat ES-SCLC. Researchers will also look at giving the study medicines with standard treatment. Gocatamig is a T-cell engager therapy. I-DXd is an antibody drug conjugate. * T-cell engager therapy is a certain type of immunotherapy that uses T-cells to find and destroy cancer cells. * A T-cell is a type of white blood cell, which are cells that help the body fight infection. * An antibody drug conjugate (ADC) is a treatment that attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of combining gocatamig and I-DXd and if people tolerate them together * If people who receive gocatamig and I-DXd have ES-SCLC respond, which means the cancer gets smaller or goes away
Official title: A Phase 1b/2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2026-01-29
Completion Date
2030-12-30
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Gocatamig
Intravenous (IV) administration
I-DXd
IV administration
Atezolizumab
IV administration
Carboplatin
IV administration
Etoposide
IV administration
Rescue Medications
Participants will receive rescue medications at the investigator's discretion. Recommended rescue medications include tocilizumab for treatment of cytokine release syndrome (CRS); dexamethasone, acetaminophen, and diphenhydramine for CRS/infusion-related reaction (IRR) prophylaxis; and 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist, and corticosteroid for prevention of nausea and vomiting.
Locations (10)
Orlando Health Cancer Institute ( Site 0108)
Orlando, Florida, United States
Saint Elizabeth Medical Center Edgewood ( Site 0112)
Edgewood, Kentucky, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101)
Hackensack, New Jersey, United States
Beijing Cancer Hospital ( Site 1604)
Beijing, Beijing Municipality, China
Shanghai East Hospital ( Site 1600)
Shanghai, Shanghai Municipality, China
Taizhou Hospital of Zhejiang Province ( Site 1601)
Taizhou, Zhejiang, China
Rambam Health Care Campus ( Site 0602)
Haifa, Israel
Sheba Medical Center ( Site 0601)
Ramat Gan, Israel
Asan Medical Center ( Site 1404)
Seoul, South Korea
Samsung Medical Center ( Site 1401)
Seoul, South Korea