A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)

Last updated: August 12, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Small Cell Lung Cancer

Treatment

Gocatamig

Ifinatamab Deruxtecan (I-DXd)

Gacatamig

Clinical Study ID

NCT06780137
6070-002
2024-517926-25
MK-6070-002
jRCT2031250039
2024-517926-25-00
  • Ages > 18
  • All Genders

Study Summary

Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment.

The goals of this study are to learn:

  • If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated

  • If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has histologically or cytologically confirmed SCLC that is extensive stage (definedas Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemictherapy that included platinum-based chemotherapy

  • Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample

  • Human immunodeficiency virus (HIV) infected participants must have well controlledHIV on antiretroviral therapy (ART)

Exclusion

Exclusion Criteria:

  • Pleural effusion, pericardial effusion, or ascites requiring recurrent drainageprocedure

  • History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that requiredsteroids or has current pneumonitis/ILD, and or suspected ILD/pneumonitis

  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonaryillnesses

  • Active or history of immune deficiency with the exception of HIV-infectedparticipants with well controlled HIV on ART

  • History within 6 months before the first dose of study intervention ofcoronary/peripheral artery bypass graft and/or any coronary/peripheral angioplastyor clinically significant cardiovascular disease such as myocardial infarction,symptomatic congestive heart failure (CHF) (New York Heart Association > class II),and/or uncontrolled cardiac arrhythmia

  • History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6months before the first dose of study intervention

  • Active clinically significant infection requiring systemic therapy

  • History of allogeneic tissue/solid organ transplant

  • History of leptomeningeal disease

  • Received prior radiotherapy within 2 weeks of start of study intervention, or hasradiation-related toxicities, requiring corticosteroids

  • Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily ofprednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention

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

  • Untreated or symptomatic brain metastases

  • Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M [IgM] positive in the setting of associated signs/symptoms), hepatitis B (hepatitisB virus surface antigen [HbsAg] positive and/or detectable hepatitis B virus [HBV]deoxyribonucleic acid [DNA]), or hepatitis C (hepatitis C virus [HCV] antibodypositive and detectable HCV ribonucleic acid). Participants with HBV withundetectable viral load after treatment are eligible. Participants with HCV withundetectable virus after treatment are eligible.

  • Part 1 only: Radiation therapy to the lung >30 Gy within 6 months before the startof study intervention

  • Part 1 only: Abdominal radiation within 4 weeks before start of study intervention

  • Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasinghormone [LHRH]) within 2 weeks before start of study intervention

  • Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy)or investigational agents within 3 weeks or 5 half-lives, whichever is longer

  • Part 1 only: Antibody-based cancer therapy within 3 weeks before start of studyintervention

  • Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of studyintervention

  • Part 1 only: Clinically significant corneal disease

  • Part 1 only: Has other uncontrolled or significant protocol-specified cardiovasculardisease

Study Design

Total Participants: 242
Treatment Group(s): 5
Primary Treatment: Gocatamig
Phase: 1/2
Study Start date:
February 27, 2025
Estimated Completion Date:
August 31, 2029

Study Description

This study will consist of two parts. Part 1 will assess the safety, tolerability, and efficacy of gocatamig and I-DXd at doses determined in study MK-6070-001 (NCT: NCT04471727). Part 2 will assess the safety and tolerability of gocatamig in participants in Japan and China. Part 3 will assess the safety, tolerability, and efficacy of gocatamig with durvalumab.

Connect with a study center

  • Princess Alexandra Hospital ( Site 5300)

    Wooloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Bradfordhill ( Site 2101)

    Santiago, Region M. De Santiago 8420383
    Chile

    Active - Recruiting

  • FALP ( Site 2100)

    Santiago., Region M. De Santiago 7500921
    Chile

    Active - Recruiting

  • Rambam Health Care Campus ( Site 3202)

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center ( Site 3200)

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 3201)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • Sheba Medical Center... ( Site 3201)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • National Cancer Center Hospital East ( Site 5001)

    Kashiwa, Chiba 277-0882
    Japan

    Active - Recruiting

  • Kansai Medical University Hospital ( Site 5004)

    Hirakata, Osaka 573-1191
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of JFCR ( Site 5002)

    Koto, Tokyo 135-8550
    Japan

    Active - Recruiting

  • Samsung Medical Center ( Site 5101)

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital ( Site 5100)

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)

    L Eixample, Barcelona 08036
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia - L'Hospitalet ( Site 3317)

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos... ( Site 3316)

    Madrid, Madrid, Comunidad De 28040
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron ( Site 3311)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro ( Site 3313)

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria ( Site 3312)

    Malaga, 29010
    Spain

    Active - Recruiting

  • Ankara Bilkent Sehir Hastanesi ( Site 3412)

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Hacettepe Universite Hastaneleri ( Site 3410)

    Ankara, 06230
    Turkey

    Active - Recruiting

  • University of Chicago ( Site 1108)

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute ( Site 1105)

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Providence Portland Medical Center ( Site 1101)

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute ( Site 7001)

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

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