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Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)

StatusActive, Not Recruiting
PhasePhase 3
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 15 words Secondary endpoints: details revised at 3 of 9 entries · Study description expanded, about 10 words · Site details revised at 15 of 247 sites Show 3 more changesShow less
    • Secondary endpoints: details revised at 3 of 9 entries
    • Study description expanded, about 10 words
    • Site details revised at 15 of 247 sites
  2. 6 versions Re-verified since Apr 7, 2026, no change to tracked fieldsv20-v25
  3. Enrollment target: estimated 190 to confirmed 191 Study sites: 245 to 247 · Secondary endpoints: details revised at 2 of 9 entriesv19 Show 2 more changesShow less
    • Study sites: 245 to 247
    • Secondary endpoints: details revised at 2 of 9 entries
  4. Re-verified, no change to tracked fieldsv18
  5. Enrollment target: 702 to 190 Primary completion date: Jun 30, 2028 to Jul 30, 2027 · Completion date: Oct 31, 2029 to Sep 30, 2028v17 Show 2 more changesShow less
    • Primary completion date: Jun 30, 2028 to Jul 30, 2027
    • Completion date: Oct 31, 2029 to Sep 30, 2028
Show 15 earlier versionsHide 15 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Study sites: 247 to 245v16 Show 1 more changeShow less
    • Study sites: 247 to 245
  2. Study sites: 238 to 247v15
  3. Primary completion date: Jan 31, 2027 to Jun 30, 2028 Study sites: 231 to 238 · Eligibility criteria expanded, about 23 words · Study description expanded, about 7 wordsv14 Show 3 more changesShow less
    • Study sites: 231 to 238
    • Eligibility criteria expanded, about 23 words
    • Study description expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 221 to 231v13
  5. Study sites: 201 to 221v12
  6. Study sites: 174 to 201v11
  7. Study sites: 134 to 174v10
  8. Study sites: 32 to 134 Eligibility criteria expanded, about 11 words · Secondary endpoints: 8 to 9 · Study description expanded, about 8 words · 1 morev9 Show 4 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 8 to 9
    • Study description expanded, about 8 words
    • Collaborators shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 19 to 32v8
  10. Re-verified, no change to tracked fieldsv7
  11. Study sites: 16 to 19v6
  12. Study sites: 5 to 16v5
  13. Re-verified, no change to tracked fieldsv4
  14. Study sites: 1 to 5 Start date changed from estimate of Nov 30, 2024 to Nov 25, 2024v3 Show 1 more changeShow less
    • Start date changed from estimate of Nov 30, 2024 to Nov 25, 2024
  15. Start date: Oct 31, 2024 to Nov 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 multicenter, randomized, open-label, international, Phase 3 trial to evaluate the efficacy and safety of acasunlimab in combination with pembrolizumab versus docetaxel (standard of care) in participants with locally advanced (unresectable stage IIIB/C) or programmed death ligand 1 (PD-L1)-positive metastatic non-small cell lung cancer (NSCLC) who have been treated with programmed cell death protein 1 (PD-1)/PD-L1 inhibitor and platinum-containing chemotherapy, administered either in combination or sequentially in the locally advanced (unresectable stage IIIB/C) or metastatic setting.
Trial Details
NCT Number NCT06635824
Lead Sponsor Genmab
Conditions PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC
Enrollment 191 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov