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Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites reduced: 56 → 52 locations Eligibility criteria expanded, about 22 words · Secondary endpoints: details revised at 2 of 16 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 2 of 16 entries
  2. Trial sites reduced: 63 → 56 locationsv25
  3. Enrollment target: 101 to 102v24
  4. Enrollment target: 100 to 101v23
  5. Enrollment target: 74 to 100v22
Show 20 earlier versionsHide 20 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 176 to confirmed 74 · Study sites: 73 to 63v21 Show 2 more changesShow less
    • Enrollment target: estimated 176 to confirmed 74
    • Study sites: 73 to 63
  2. Study sites revised (73)v20 See this version in full on ClinicalTrials.gov ↗
  3. Site details revised at 1 of 73 sitesv19
  4. Eligibility criteria revised Site details revised at 11 of 73 sitesv18 Show 1 more changeShow less
    • Site details revised at 11 of 73 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 1 of 73 sitesv17
  6. Site details revised at 3 of 73 sitesv16
  7. Site details revised at 3 of 73 sitesv15
  8. Site details revised at 6 of 73 sitesv14
  9. Site details revised at 3 of 73 sites Eligibility criteria expanded, about 4 wordsv13 Show 1 more changeShow less
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  10. Site details revised at 2 of 73 sitesv12
  11. Site details revised at 4 of 73 sitesv11
  12. Study sites revised (73)v10 See this version in full on ClinicalTrials.gov ↗
  13. Study sites revised (73)v9 See this version in full on ClinicalTrials.gov ↗
  14. Re-verified, no change to tracked fieldsv8
  15. Study sites: 72 to 73 Start date changed from estimate of Aug 31, 2024 to Aug 7, 2024v7 Show 1 more changeShow less
    • Start date changed from estimate of Aug 31, 2024 to Aug 7, 2024
  16. Start date: Jul 26, 2024 to Aug 31, 2024 Study sites: 8 to 72v6 Show 1 more changeShow less
    • Study sites: 8 to 72
  17. Trial status: Not Yet Recruiting to Recruiting Start date: Jun 7, 2024 to Jul 26, 2024 · Site details revised at 8 of 8 sitesv5 Show 2 more changesShow less
    • Start date: Jun 7, 2024 to Jul 26, 2024
    • Site details revised at 8 of 8 sites
  18. Study sites: 0 to 8v4
  19. Start date: Apr 30, 2024 to Jun 7, 2024v3
  20. Start date: Apr 1, 2024 to Apr 30, 2024v2
  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.
This is a Phase 1b/2 study evaluating the anti-PD1 antibody, cemiplimab, in combination with either S095018 (anti-TIM3 antibody), S095024 (anti-CD73 antibody), or S095029 (anti-NKG2A antibody) in adult participants with previously untreated advanced/metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. The study includes two parts: part A, the combination-therapy safety lead-in phase to determine the recommended dose for expansion (RDE) for S095018, S095024, and S095029 in combination with cemiplimab and part B, the randomized dose expansion phase to assess the efficacy of S095018, S095024, or S095029 in combination with cemiplimab. Study treatment will be administered for a maximum of 108 weeks, or until confirmed disease progression per iRECIST and/ or until meeting other treatment discontinuation criteria.
Trial Details
NCT Number NCT06162572
Lead Sponsor Servier Bio-Innovation LLC
Collaborators: Institut de Recherches Internationales Servier, Regeneron Pharmaceuticals
Conditions Non-small Cell Lung Cancer (NSCLC)
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov