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NCT07227597PHASE1, PHASE2Recruiting

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

Merck Sharp & Dohme LLC

Start Date

1/29/2026

Completion Date

12/30/2030

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

Detailed Description

In Part A, participants will be allocated to Arm 1 or Arm 2 per investigator's discretion. In Part B, participants will be allocated to Arm 1 per investigator's discretion and randomized to Arms 2, 3, and 4.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) * For participants receiving gocatamig + ifinatamab deruxtecan (I-DXd) in maintenance only: * Completed 3 to 4 cycles of platinum + etoposide chemotherapy with concurrent approved anti-programmed cell death 1/Ligand 1 (anti PD-1/L1) as first line (1L) treatment of ES-SCLC within 6 weeks prior to enrollment * No radiological disease progression per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) * No other prior systemic ES-SCLC therapy allowed * Rechallenge therapy counts as an additional line and leads to exclusion * For participants receiving gocatamig + I-DXd in induction and maintenance, or gocatamig + I-DXd in induction followed by gocatamig + atezolizumab in maintenance, or carboplatin + etoposide + atezolizumab in induction followed by atezolizumab in maintenance: No prior systemic ES-SCLC treatment allowed * Applicable to all participants: prior limited-stage small cell lung cancer (SCLC) is allowed if \> 6 months have passed since the end of previous therapy and progression * Must be able to provide a pretreatment archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated * Measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if growth has been shown in such lesions since the completion of radiation Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, current ILD, ILD that cannot be ruled out by imaging at screening, or suspected ILD * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Has history of clinically significant intracranial bleeding or spinal cord bleeding * Has active neurologic paraneoplastic syndrome * Has history of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF), and/or uncontrolled cardiac arrhythmia within 6 months before the first dose of study intervention * Has other uncontrolled or significant protocol specified cardiovascular disease * Has history of arterial thrombosis within 6 months before the first dose of study intervention * Has chronic liver disease * Has history of allogeneic tissue/solid organ transplant * Has history of leptomeningeal disease * Is infected with human immunodeficiency virus (HIV) and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor * Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has major surgery within 4 weeks or minor surgery within 2 weeks of allocation/randomization (or first dose), or is anticipated to require a major surgical procedure during the study

Interventions

DRUG

Gocatamig

DRUG

I-DXd

DRUG

Atezolizumab

DRUG

Carboplatin

DRUG

Etoposide

DRUG

Rescue Medications

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Conditions

Small Cell Lung Cancer Extensive Stage

Locations

Providence Medical Foundation ( Site 0124)

Santa Rosa, California 95403

United States

University of Colorado, Anschutz Cancer Pavilion ( Site 0125)

Aurora, Colorado 80045

United States

Orlando Health Cancer Institute ( Site 0108)

Orlando, Florida 32806

United States

Saint Elizabeth Medical Center Edgewood ( Site 0112)

Edgewood, Kentucky 41017

United States

Washington University School of Medicine ( Site 0134)

St Louis, Missouri 63110

United States

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

Hackensack, New Jersey 07601

United States

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

Portland, Oregon 97213

United States

Avera Cancer Institute- Research ( Site 0104)

Sioux Falls, South Dakota 57105

United States

The University of Tennessee Medical Center ( Site 0120)

Knoxville, Tennessee 37920

United States

Lt. Col. Luke Weathers, Jr. VA Medical Center ( Site 0133)

Memphis, Tennessee 38105

United States

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee 37203

United States

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

Houston, Texas 77030

United States

University of Virginia Health System ( Site 0122)

Charlottesville, Virginia 22908

United States

CEMIC ( Site 1903)

Caba., Buenos Aires C1431FWO

Argentina

Hospital Austral ( Site 1901)

Pilar, Buenos Aires B1629AHJ

Argentina

Sanatorio Parque ( Site 1900)

Rosario, Santa Fe Province S2000DSV

Argentina

FALP ( Site 0200)

Santiago, Region M. de Santiago 7500921

Chile

Pontificia Universidad Catolica de Chile ( Site 0202)

Santiago, Region M. de Santiago 8330032

Chile

Bradfordhill ( Site 0201)

Santiago, Region M. de Santiago 8420383

Chile

Beijing Cancer Hospital ( Site 1604)

Beijing, Beijing Municipality 100142

China

Southern Medical University Nanfang Hospital ( Site 1608)

Guangzhou, Guangdong 510515

China

Jiangmen Central Hospital ( Site 1611)

Jiangmen, Guangdong 529000

China

The First Affiliated Hospital of Nanchang University ( Site 1610)

Nanchang, Jiangxi 330209

China

Shanghai East Hospital ( Site 1600)

Shanghai, Shanghai Municipality 200000

China

Sichuan Cancer hospital. ( Site 1609)

Chengdu, Sichuan 610213

China

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

Hangzhou, Zhejiang 310003

China

Taizhou Hospital of Zhejiang Province ( Site 1601)

Taizhou, Zhejiang 317000

China

Universitaetsklinikum Jena ( Site 0403)

Jena, Thuringia 07747

Germany

Rambam Health Care Campus ( Site 0602)

Haifa, 3109601

Israel

Sheba Medical Center ( Site 0601)

Ramat Gan, 5265601

Israel

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0701)

Milan, 20133

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0700)

Roma, 00168

Italy

Seoul National University Hospital ( Site 1402)

Seoul, 03080

South Korea

Severance Hospital Yonsei University Health System ( Site 1403)

Seoul, 03722

South Korea

Asan Medical Center ( Site 1404)

Seoul, 05505

South Korea

Samsung Medical Center ( Site 1401)

Seoul, 06351

South Korea

Hospital San Pedro ( Site 1004)

Logroño, La Rioja 26006

Spain

Hospital Universitario Insular de Gran Canaria ( Site 1002)

Las Palmas de Gran Canaria, Las Palmas 35016

Spain

Hospital Universitari Vall d'Hebron ( Site 1001)

Barcelona, 08035

Spain

Hospital Universitario Gregorio Maranon ( Site 1003)

Madrid, 28007

Spain

Faculty of Medicine Siriraj Hospital ( Site 3000)

Bangkoknoi, Bangkok 10700

Thailand

Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002)

Dusit, Bangkok 10300

Thailand

Songklanagarind hospital ( Site 3001)

Hat Yai, Changwat Songkhla 90110

Thailand