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

Last updated: June 24, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Atezolizumab

Carboplatin

Gocatamig

Clinical Study ID

NCT07227597
6070-003
2025-521032-11-00
MK-6070-003
U1111-1318-5025
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has a histologically or cytologically confirmed diagnosis of extensive-stage smallcell lung cancer (ES-SCLC)

  • For participants receiving gocatamig + ifinatamab deruxtecan (I-DXd) in maintenanceonly:

  • Completed 3 to 4 cycles of platinum + etoposide chemotherapy with concurrentapproved 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 SolidTumors 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, orgocatamig + I-DXd in induction followed by gocatamig + atezolizumab in maintenance,or carboplatin + etoposide + atezolizumab in induction followed by atezolizumab inmaintenance: No prior systemic ES-SCLC treatment allowed

  • Applicable to all participants: prior limited-stage small cell lung cancer (SCLC) isallowed 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 newlyobtained core, incisional, or excisional biopsy of a tumor lesion not previouslyirradiated

  • Measurable disease by RECIST 1.1 as assessed by the local siteinvestigator/radiology. Lesions situated in a previously irradiated area areconsidered measurable if growth has been shown in such lesions since the completionof radiation

Exclusion

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainageprocedures

  • Has any history of interstitial lung disease (ILD)/pneumonitis irrespective ofsteroid use, current ILD, ILD that cannot be ruled out by imaging at screening, orsuspected ILD

  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonaryillnesses

  • 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 anycoronary/peripheral angioplasty or clinically significant cardiovascular diseasesuch as myocardial infarction, symptomatic congestive heart failure (CHF), and/oruncontrolled cardiac arrhythmia within 6 months before the first dose of studyintervention

  • Has other uncontrolled or significant protocol specified cardiovascular disease

  • Has history of arterial thrombosis within 6 months before the first dose of studyintervention

  • 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'ssarcoma 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 deathligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory orcoinhibitory T-cell receptor

  • Has received prior radiotherapy within 2 weeks of start of study intervention, orhas radiation-related toxicities, requiring corticosteroids

  • Has known additional malignancy that is progressing or has required active treatmentwithin the past 3 years

  • Has active autoimmune disease that has required systemic treatment in the past 2years except replacement therapy

  • Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis

  • Has major surgery within 4 weeks or minor surgery within 2 weeks ofallocation/randomization (or first dose), or is anticipated to require a majorsurgical procedure during the study

Study Design

Total Participants: 170
Treatment Group(s): 6
Primary Treatment: Atezolizumab
Phase: 1/2
Study Start date:
January 29, 2026
Estimated Completion Date:
December 30, 2030

Study 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.

Connect with a study center

  • CEMIC ( Site 1903)

    Caba., Buenos Aires C1431FWO
    Argentina

    Active - Recruiting

  • Hospital Austral ( Site 1901)

    Pilar, Buenos Aires B1629AHJ
    Argentina

    Active - Recruiting

  • Bradfordhill ( Site 0201)

    Santiago, Region M. de Santiago 8420383
    Chile

    Active - Recruiting

  • FALP ( Site 0200)

    Santiago, Region M. de Santiago 7500921
    Chile

    Active - Recruiting

  • Pontificia Universidad Catolica de Chile ( Site 0202)

    Santiago, Region M. de Santiago 8330032
    Chile

    Active - Recruiting

  • Beijing Cancer Hospital ( Site 1604)

    Beijing, Beijing Municipality 100142
    China

    Active - Recruiting

  • Southern Medical University Nanfang Hospital ( Site 1608)

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • Jiangmen Center Hospital ( Site 1611)

    Jiangmen, Guangdong 529000
    China

    Active - Recruiting

  • Jiangmen Central Hospital ( Site 1611)

    Jiangmen, Guangdong 529000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University ( Site 1610)

    Nanchang, Jiangxi 330209
    China

    Active - Recruiting

  • Shanghai East Hospital ( Site 1600)

    Shanghai, Shanghai Municipality 200000
    China

    Active - Recruiting

  • Sichuan Cancer hospital. ( Site 1609)

    Chengdu, Sichuan 610213
    China

    Active - Recruiting

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

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • Taizhou Hospital of Zhejiang Province ( Site 1601)

    Taizhou, Zhejiang 317000
    China

    Active - Recruiting

  • Rambam Health Care Campus ( Site 0602)

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 0601)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • Asan Medical Center ( Site 1404)

    Seoul, 05505
    South Korea

    Active - Recruiting

  • Samsung Medical Center ( Site 1401)

    Seoul, 06351
    South Korea

    Active - Recruiting

  • Seoul National University Hospital ( Site 1402)

    Seoul, 03080
    South Korea

    Active - Recruiting

  • Severance Hospital Yonsei University Health System ( Site 1403)

    Seoul, 03722
    South Korea

    Active - Recruiting

  • Hospital Universitario Insular de Gran Canaria ( Site 1002)

    Las Palmas de Gran Canaria, Las Palmas 35016
    Spain

    Active - Recruiting

  • Providence Medical Foundation ( Site 0124)

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Orlando Health Cancer Institute ( Site 0108)

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Saint Elizabeth Medical Center Edgewood ( Site 0112)

    Edgewood, Kentucky 41017
    United States

    Active - Recruiting

  • Washington University School of Medicine ( Site 0134)

    St Louis, Missouri 63110
    United States

    Active - Recruiting

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

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

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

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Avera Cancer Institute- Research ( Site 0104)

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • The University of Tennessee Medical Center ( Site 0120)

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

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

    Memphis, Tennessee 38105
    United States

    Active - Recruiting

  • SCRI Oncology Partners ( Site 7000)

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

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

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Virginia Health System ( Site 0122)

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

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