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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT06780137

Registry updated: 2026-10-06
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Description

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

Interventions

  • Gocatamig (Biological)
    IV infusion
  • Ifinatamab Deruxtecan (I-DXd) (Biological)
    IV infusion
  • Durvalumab (Biological)
    IV infusion

Eligibility criteria

Inclusion Criteria: * Has histologically or cytologically confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy 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 controlled HIV on antiretroviral therapy (ART) Exclusion Criteria: * Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure * Any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use except for a history of radiation pneumonitis that did not require steroids * Current history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART * History within 6 months before the first dose of study intervention 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) (New York Heart Association \> class II), and/or uncontrolled cardiac arrhythmia * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months 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 has radiation-related toxicities, requiring corticosteroids * Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone 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 treatment within 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 (hepatitis B virus surface antigen \[HbsAg\] positive and/or detectable hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\]), or hepatitis C (hepatitis C virus \[HCV\] antibody positive and detectable HCV ribonucleic acid). Participants with HBV with undetectable viral load after treatment are eligible. Participants with HCV with undetectable virus after treatment are eligible. * Part 1 only: Radiation therapy to the lung \>30 Gy within 6 months before the start of study intervention * Part 1 only: Abdominal radiation within 4 weeks before start of study intervention * Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone \[LHRH\]) 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 study intervention * Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention * Part 1 only: Clinically significant corneal disease * Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease

Conditions

Small Cell Lung Cancer

Locations

  • University of Colorado Anschutz Medical Campus ( Site 1110) — Aurora, Colorado, United States
  • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111) — Miami, Florida, United States
  • University of Chicago ( Site 1108) — Chicago, Illinois, United States
  • Dana Farber Cancer Institute ( Site 1105) — Boston, Massachusetts, United States
  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103) — Hackensack, New Jersey, United States
  • Roswell Park Cancer Institute ( Site 1107) — Buffalo, New York, United States
  • Providence Portland Medical Center ( Site 1101) — Portland, Oregon, United States
  • Sarah Cannon Research Institute ( Site 7001) — Nashville, Tennessee, United States
  • Medical College of Wisconsin ( Site 1112) — Milwaukee, Wisconsin, United States
  • Hospital Universitario Austral ( Site 2204) — Pilar, Buenos Aires, Argentina
  • Sanatorio Parque ( Site 2203) — Rosario, Santa Fe Province, Argentina
  • Princess Alexandra Hospital ( Site 5300) — Woolloongabba, Queensland, Australia
  • Monash Health ( Site 5301) — Clayton, Victoria, Australia
  • FALP ( Site 2100) — Santiago, Region M. de Santiago, Chile
  • Pontificia Universidad Catolica de Chile ( Site 2102) — Santiago, Region M. de Santiago, Chile
  • Bradfordhill ( Site 2101) — Santiago, Region M. de Santiago, Chile
  • Beijing Cancer Hospital ( Site 5401) — Beijing, Beijing Municipality, China
  • Fujian Cancer Hospital ( Site 5413) — Fuzhou, Fujian, China
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403) — Nanjing, Jiangsu, China
  • Shanghai Chest Hospital ( Site 5400) — Shanghai, Shanghai Municipality, China
  • Shanghai Pulmonary Hospital ( Site 5405) — Shanghai, Shanghai Municipality, China
  • West China Hospital of Sichuan University ( Site 5416) — Chengdu, Sichuan, China
  • The First Affiliated Hospital, Zhejiang University ( Site 5404) — Hangzhou, Zhejiang, China
  • Rambam Health Care Campus ( Site 3202) — Haifa, Israel
  • Shaare Zedek Medical Center ( Site 3200) — Jerusalem, Israel
  • Rabin Medical Center ( Site 3203) — Petah Tikva, Israel
  • Sheba Medical Center ( Site 3201) — Ramat Gan, Israel
  • Aichi Cancer Center ( Site 5000) — Nagoya, Aichi-ken, Japan
  • National Cancer Center Hospital East ( Site 5001) — Kashiwa, Chiba, Japan
  • Kansai Medical University Hospital ( Site 5004) — Hirakata, Osaka, Japan
  • Cancer Institute Hospital of JFCR ( Site 5002) — Koto, Tokyo, Japan
  • Seoul National University Hospital ( Site 5100) — Seoul, South Korea
  • Severance Hospital, Yonsei University Health System ( Site 5102) — Seoul, South Korea
  • Samsung Medical Center ( Site 5101) — Seoul, South Korea
  • HOSPITAL CLÍNIC DE BARCELONA ( Site 3310) — Eixample, Barcelona, Spain
  • Institut Català d'Oncologia - L'Hospitalet ( Site 3317) — L'Hospitalet de Llobregat, Barcelona, Spain
  • Hospital Clinico San Carlos... ( Site 3316) — Madrid, Madrid, Comunidad de, Spain
  • Hospital Universitari Vall d'Hebron ( Site 3311) — Barcelona, Spain
  • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315) — Madrid, Spain
  • Hospital Universitario HM Sanchinarro ( Site 3313) — Madrid, Spain
  • Hospital Universitario Virgen de la Victoria ( Site 3312) — Málaga, Spain
  • National Cheng Kung University Hospital ( Site 5202) — Tainan, Taiwan
  • Taipei Medical University Hospital ( Site 5201) — Taipei, Taiwan
  • Hacettepe Universite Hastaneleri ( Site 3410) — Ankara, Turkey (Türkiye)
  • Ankara Bilkent Sehir Hastanesi ( Site 3412) — Ankara, Turkey (Türkiye)
  • National Institute for Health Research UCLH Clinical Research Facility ( Site 3902) — London, London, City of, United Kingdom
  • The Clatterbridge Cancer Centre ( Site 3903) — Liverpool, United Kingdom
  • The Christie NHS Foundation Trust ( Site 3901) — Manchester, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record