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

StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Trial sites expanded: 54 → 57 locations
  2. Study sites: 54 to 55
  3. Study sites: 53 to 54
  4. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC
    • Study sites: 52 to 53
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 9 of 22 entries
  5. Trial sites expanded: 7 → 52 locationsv22
  6. Trial sites reduced: 45 → 7 locationsv21
  7. Study sites: 43 to 45v20
  8. Trial sites expanded: 37 → 43 locationsv19
  9. Study sites: 35 to 37v18
  10. Study sites: 33 to 35v17
  11. Study sites: 32 to 33v16
  12. Study sites: 31 to 32v15
  13. Trial sites expanded: 28 → 31 locationsv14
  14. Study sites: 27 to 28v13
  15. Study sites: 25 to 27v12
  16. Study sites: 23 to 25v11
  17. Trial sites expanded: 15 → 23 locationsv10
  18. Study sites: 13 to 15v9
  19. Trial sites expanded: 10 → 13 locationsv8
  20. Study sites: 9 to 10v7
  21. Trial sites expanded: 2 → 9 locationsv6
  22. Study completion date: Nov 29, 2030 to Dec 30, 2030v5
  23. Re-verified, no change to tracked fieldsv4
  24. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Jan 14, 2026 to Jan 29, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 22 of 22 entries
  25. Start date: Dec 12, 2025 to Jan 14, 2026v2
  26. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Merck (MSD)
411 trials monitored
See 26 trials at risk
Lung Cancer
4,803 trials monitored
See 272 trials at risk
Small Cell Lung Cancer
564 trials monitored
See 35 trials at risk
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
Trial Details
NCT Number NCT07227597
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Daiichi Sankyo
Conditions
(from sponsor)		 Small Cell Lung Cancer Extensive Stage
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov