N-803 + Tislelizumab+ Docetaxel Vs Docetaxel Mono in Adv or Met NSCLC

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  1012227

• Contact name

  Charles Garlisi

• Contact email

  charles.garlisi@ImmunityBio.com

• Sponsor organisation

  ImmunityBio, Inc

• Eudract number

  2025-521221-32

• Clinicaltrials.gov Identifier

  NCT06745908

• Research summary

  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]/ROS proto-oncogene 1, receptor tyrosine kinase [ROS1] vs OTHER AGA vs No AGA).

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  25/NE/0097

• Date of REC Opinion

  2 Sep 2025

• REC opinion

  Further Information Favourable Opinion