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Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 19 → 36 locationsv19
  2. Re-verified, no change to tracked fieldsv18
  3. Enrollment increased: 460 → 507 participants Trial arms changed: 2 → 4 · Site contacts updated at 3 of 19 sites · Study title shortened, about 5 wordsv17 Show 3 more changesShow less
    • Trial arms changed: 2 → 4
    • Site contacts updated at 3 of 19 sites
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. Enrollment target: 460 to 507 Interventions: Docetaxel (Drug), N-803 (Drug), Tislelizumab (Drug) to Docetaxel (Drug), N-803 (Drug), Prior failed checkpoint inhibitor (Drug), Tislelizumab (Drug) · Eligibility criteria expanded, about 1,584 words · Study title expanded, about 18 words · 1 morev16 Show 4 more changesShow less
    • Interventions: Docetaxel (Drug), N-803 (Drug), Tislelizumab (Drug) to Docetaxel (Drug), N-803 (Drug), Prior failed checkpoint inhibitor (Drug), Tislelizumab (Drug)
    • Eligibility criteria expanded, about 1,584 words
    • Study title expanded, about 18 words
    • Study arms: 2 to 4

    See this version in full on ClinicalTrials.gov ↗

  5. Site contacts updated at 3 of 19 sitesv15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 17 to 19v14
  2. Study sites: 9 to 17v13
  3. Study sites: 5 to 9 Start date changed from estimate of Sep 2025 to Oct 1, 2025v12 Show 1 more changeShow less
    • Start date changed from estimate of Sep 2025 to Oct 1, 2025
  4. Study sites revised (5)v11 See this version in full on ClinicalTrials.gov ↗
  5. Site contacts updated at 2 of 5 sitesv10
  6. Start date: May 2025 to Sep 2025 Study sites: 2 to 5v9 Show 1 more changeShow less
    • Study sites: 2 to 5
  7. Trial status: Not Yet Recruiting to Recruiting Start date: Mar 2025 to May 2025 · Study sites: 0 to 2v8 Show 2 more changesShow less
    • Start date: Mar 2025 to May 2025
    • Study sites: 0 to 2
  8. Start date: Feb 2025 to Mar 2025v7
  9. Start date: Jan 2025 to Feb 2025 Interventions: ANKTIVA (Drug), Docetaxel (Drug), Tislelizumab (Drug) to Docetaxel (Drug), N-803 (Drug), Tislelizumab (Drug) · Study title revisedv6 Show 2 more changesShow less
    • Interventions: ANKTIVA (Drug), Docetaxel (Drug), Tislelizumab (Drug) to Docetaxel (Drug), N-803 (Drug), Tislelizumab (Drug)
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  10. Re-verified, no change to tracked fieldsv5
  11. Interventions: ANKTIVA (Drug), Docetaxel (Drug), Nivolumab (Drug) to ANKTIVA (Drug), Docetaxel (Drug), Tislelizumab (Drug) Eligibility criteria expanded, about 34 words · Study title revisedv4 Show 2 more changesShow less
    • Eligibility criteria expanded, about 34 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  12. Study title expanded, about 1 wordv3 See this version in full on ClinicalTrials.gov ↗
  13. Study title shortened, about 2 wordsv2 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.
This is a randomized, two-cohort, open-label, phase 3, clinical trial to compare the efficacy and safety of N-803 plus tislelizumab and docetaxel (cohort A) or prior failed Health Authority-approved antiprogrammed death-1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) CPI and docetaxel (cohort B) versus docetaxel monotherapy (cohorts A and B). For each cohort, enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm. For cohort A, the randomization will be stratified by geographical region (North America vs Europe vs Asia vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA) (epidermal growth factor receptor \[EGFR\]/anaplastic lymphoma kinase \[ALK\]/ROS proto-oncogene 1, receptor tyrosine kinase \[ROS1\] vs Other AGA vs No AGA). For cohort B, the randomization will be stratified by geographical region (Americas vs Asia Pacific \[PAC\] vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA) (Yes vs No).
Trial Details
NCT Number NCT06745908
Lead Sponsor ImmunityBio, Inc.
Conditions NSCLC Stage IV
Enrollment 507 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov