ResQ201A: N-803 Plus TISLELIZUMAB And DOCETAXEL vs DOCETAXEL Monotherapy In NSCLC
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ResQ201A: Randomized, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy
- Sex: Any
- Age: Adult (18 - 64), Older Adult (65+)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase I
- Conditions Being Studied: Cancer - Lung
Study Purpose
This is a randomized, open-label, phase 3 clinical trial to compare the efficacy and safety of N-803 plus tislelizumab and docetaxel (experimental arm) versus docetaxel monotherapy (control arm). Enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm. Participant 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] vs OTHER AGA vs No AGA).
- UH IRB: STUDY20250608 / Pro00087337
- StudyID: IMBI1525
- ClinicalTrials.gov: NCT06745908
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