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RECRUITING
NCT07227597
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Gocatamig

Intravenous (IV) administration

DRUG

I-DXd

IV administration

DRUG

Atezolizumab

IV administration

DRUG

Carboplatin

IV administration

DRUG

Etoposide

IV administration

DRUG

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