A Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).

StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Primary completion moved earlier from Apr 6, 2028 to Aug 17, 2027
    • Study completion moved earlier from Sep 5, 2031 to Jul 14, 2031
    • Eligibility criteria expanded, about 6 words
    • Site details revised at 6 of 183 sites
  2. Interventions modified
    • Study title revised
    v35
  3. Site details revised at 4 of 183 sitesv34
  4. Study sites revised (183)v33
  5. Site details revised at 4 of 183 sitesv32
Show 30 earlier versionsHide 30 earlier versions
  1. Site details revised at 3 of 183 sitesv31
  2. Study sites revised (183)v30
  3. Study sites: 184 to 183v29
  4. Study sites revised (184)v28
  5. Study sites revised (184)v27
  6. Study sites revised (184)v26
  7. Study sites revised (184)v25
  8. Study sites revised (184)v24
  9. Study sites revised (184)v23
  10. Study sites revised (184)v22
  11. Study sites: 182 to 184v21
  12. Study sites revised (182)v20
  13. Study sites: 191 to 182v19
  14. Study sites revised (191)v18
  15. Eligibility criteria revised
    • Study sites revised (191)
    v17
  16. Study sites revised (191)v16
  17. Study sites revised (191)v15
  18. Study sites: 190 to 191v14
  19. Study sites revised (190)v13
  20. Study sites revised (190)v12
  21. Study sites revised (190)v11
  22. Study sites: 189 to 190v10
  23. Study sites: 188 to 189v9
  24. Study sites revised (188)v8
  25. Study sites revised (188)v7
  26. Study sites revised (188)v6
  27. Study sites: 153 to 188
    • Start date changed from estimate of Jan 31, 2025 to Feb 25, 2025
    v5
  28. Trial status: Not Yet Recruiting to Recruiting
    • Study sites revised (153)
    v4
  29. Study sites: 152 to 153v3
  30. Study sites: 124 to 152
    • Start date: Jan 21, 2025 to Jan 31, 2025
    v2
  1. 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.
The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.
Trial Details
NCT Number NCT06646276
Lead Sponsor Bristol-Myers Squibb
Conditions
(from sponsor)		 Extensive-Stage Small Cell Lung Cancer
Related terms Small Cell Lung Carcinoma
Enrollment 530 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov