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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

2026-05-28

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 (28)

Providence Medical Foundation ( Site 0124)

Santa Rosa, California, United States

Orlando Health Cancer Institute ( Site 0108)

Orlando, Florida, United States

Saint Elizabeth Medical Center Edgewood ( Site 0112)

Edgewood, Kentucky, United States

Washington University School of Medicine ( Site 0134)

St Louis, Missouri, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101)

Hackensack, New Jersey, United States

Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107)

Portland, Oregon, United States

Avera Cancer Institute- Research ( Site 0104)

Sioux Falls, South Dakota, United States

The University of Tennessee Medical Center ( Site 0120)

Knoxville, Tennessee, United States

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee, United States

Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113)

Houston, Texas, United States

Hospital Austral ( Site 1901)

Pilar, Buenos Aires, Argentina

FALP ( Site 0200)

Santiago, Region M. de Santiago, Chile

Pontificia Universidad Catolica de Chile ( Site 0202)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0201)

Santiago, Region M. de Santiago, Chile

Beijing Cancer Hospital ( Site 1604)

Beijing, Beijing Municipality, China

Southern Medical University Nanfang Hospital ( Site 1608)

Guangzhou, Guangdong, China

Jiangmen Central Hospital ( Site 1611)

Jiangmen, Guangdong, China

The First Affiliated Hospital of Nanchang University ( Site 1610)

Nanchang, Jiangxi, China

Shanghai East Hospital ( Site 1600)

Shanghai, Shanghai Municipality, China

Sichuan Cancer hospital. ( Site 1609)

Chengdu, Sichuan, China

The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1602)

Hangzhou, Zhejiang, 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

Seoul National University Hospital ( Site 1402)

Seoul, South Korea

Severance Hospital Yonsei University Health System ( Site 1403)

Seoul, South Korea

Asan Medical Center ( Site 1404)

Seoul, South Korea

Samsung Medical Center ( Site 1401)

Seoul, South Korea