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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)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Primary and study completion moved earlier from Apr 27, 2029 to Feb 15, 2029 · Eligibility criteria expanded, about 26 words · Secondary endpoints: details revised at 45 of 49 entries · 1 more Show 4 more changesShow less
    • Primary and study completion moved earlier from Apr 27, 2029 to Feb 15, 2029
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 45 of 49 entries
    • Site details revised at 2 of 48 sites
  2. Study sites: 46 to 48v38
  3. Study sites: 48 to 46v37
  4. Enrollment increased: 262 → 327 participants Primary completion moved earlier from Aug 31, 2029 to Apr 27, 2029 · Completion moved earlier from Jan 17, 2030 to Apr 27, 2029 · Eligibility criteria expanded, about 19 words · 1 morev36 Show 4 more changesShow less
    • Primary completion moved earlier from Aug 31, 2029 to Apr 27, 2029
    • Completion moved earlier from Jan 17, 2030 to Apr 27, 2029
    • Eligibility criteria expanded, about 19 words
    • Site contacts updated at 1 of 48 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 47 to 48v35
Show 33 earlier versionsHide 33 earlier versions
  1. Study sites: 46 to 47v34
  2. Site details revised at 1 of 46 sitesv33
  3. Study sites: 45 to 46v32
  4. Study sites: 43 to 45v31
  5. Enrollment target: 242 to 262 Study sites: 39 to 43 · Completion date: Feb 14, 2030 to Jan 17, 2030 · Eligibility criteria expanded, about 7 words · 2 morev30 Show 5 more changesShow less
    • Study sites: 39 to 43
    • Completion date: Feb 14, 2030 to Jan 17, 2030
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (49)
    • Study arms: 8 to 9

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv29
  7. Completion date: Aug 31, 2029 to Feb 14, 2030v28
  8. Study sites: 38 to 39v27
  9. Study sites: 37 to 38v26
  10. Study sites: 36 to 37v25
  11. Study sites: 35 to 36v24
  12. Study sites: 34 to 35v23
  13. Study sites: 33 to 34v22
  14. Study sites: 32 to 33v21
  15. Study sites: 31 to 32v20
  16. Study sites: 28 to 31v19
  17. Site contacts updated at 1 of 28 sitesv18
  18. Site contacts updated at 2 of 28 sitesv17
  19. Study sites: 27 to 28v16
  20. Study sites: 25 to 27v15
  21. Study sites: 23 to 25v14
  22. Study sites: 21 to 23v13
  23. Study sites: 17 to 21v12
  24. Study sites: 14 to 17v11
  25. Enrollment target: 138 to 242 Interventions: Gocatamig (Biological), Ifinatamab Deruxtecan (I-DXd) (Biological) to Durvalumab (Biological), Gocatamig (Biological), Ifinatamab Deruxtecan (I-DXd) (Biological) · Eligibility criteria expanded, about 12 words · Secondary endpoints: 44 to 49 · 2 morev10 Show 5 more changesShow less
    • Interventions: Gocatamig (Biological), Ifinatamab Deruxtecan (I-DXd) (Biological) to Durvalumab (Biological), Gocatamig (Biological), Ifinatamab Deruxtecan (I-DXd) (Biological)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 44 to 49
    • Study arms: 5 to 8
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  26. Study sites: 13 to 14v9
  27. Study sites: 12 to 13v8
  28. Primary and study completion dates: Oct 31, 2028 to Aug 31, 2029v7
  29. Study sites: 11 to 12v6
  30. Study sites: 10 to 11v5
  31. Study sites: 9 to 10v4
  32. Study sites: 1 to 9 Start date changed from estimate of Mar 1, 2025 to Feb 27, 2025 · Interventions: Gacatamig (Biological), Ifinatamab Deruxtecan (I-DXd) (Biological) to Gocatamig (Biological), Ifinatamab Deruxtecan (I-DXd) (Biological) · Secondary endpoints revised (44) · 1 morev3 Show 4 more changesShow less
    • Start date changed from estimate of Mar 1, 2025 to Feb 27, 2025
    • Interventions: Gacatamig (Biological), Ifinatamab Deruxtecan (I-DXd) (Biological) to Gocatamig (Biological), Ifinatamab Deruxtecan (I-DXd) (Biological)
    • Secondary endpoints revised (44)
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  33. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary and study completion dates: Aug 7, 2028 to Oct 31, 2028 · Start date: Feb 14, 2025 to Mar 1, 2025 · 4 morev2 Show 7 more changesShow less
    • Study sites: 0 to 1
    • Primary and study completion dates: Aug 7, 2028 to Oct 31, 2028
    • Start date: Feb 14, 2025 to Mar 1, 2025
    • Interventions: Ifinatamab Deruxtecan (I-DXd) (Biological), MK-6070 (Biological) to Gacatamig (Biological), Ifinatamab Deruxtecan (I-DXd) (Biological)
    • Secondary endpoints revised (44)
    • Study description revised
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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)
407 trials monitored
See 29 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Small Cell Lung Cancer
540 trials monitored
See 31 trials at risk
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
Trial Details
NCT Number NCT06780137
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Daiichi Sankyo
Conditions Small Cell Lung Cancer
Enrollment 327 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov