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

Conditions

• NSCLC Stage IV

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• N-803 — DRUG
  N-803 1.2 mg SC
• Tislelizumab — DRUG
  Tislelizumab 200 mg IV
• Docetaxel — DRUG
  Docetaxel 75 mg/m2 IV
• Prior failed checkpoint inhibitor — DRUG
  Previously failed checkpoint inhibitor

Study Details

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).

Key Dates

Start date

Oct 1, 2025

Status verified

Oct 2025

Primary completion

Sep 30, 2028

Completion

Jan 31, 2029

Study Design

Enrollment

507 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A: Experimental Arm
  3-week cycles. N803, Tislelizumab, and Docetaxel will be administered on Cycle 1 and 2. N803 and Tislelizumab will be administered on Cycle 3 and onward until end of study.
• Active Comparator: Cohort A: Control Arm
  The control arm treatment regimen will consist of repeated 3-week cycles with a ± 3-day window for each visit of Docetaxel 75 mg/m2 IV.
• Experimental: Cohort B: Experimental Arm
  3-week cycles. N803, prior failed checkpoint inhibitor, and Docetaxel will be administered on Cycle 1 and 2. N803 and prior failed checkpoint inhibitor will be administered on Cycle 3 and onward until end of study.
• Active Comparator: Cohort B: Control Arm
  The control arm treatment regimen will consist of repeated 3-week cycles with a ± 3-day window for each visit of Docetaxel 75 mg/m2 IV.

Primary Outcome Measure

Compare Overall Survival between the experimental and control arms [ Time Frame: Approximately 12 months ]

Central Contacts

• Phillip Trieu
  856-739-5609
  [email protected]
• Tamra Madenwald
  [email protected]

Locations (19)

Find similar trials in Springdale, AR

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