Overview

“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”

This Phase 3 clinical trial is being done to compare two treatment approaches for people with advanced or metastatic non‑small cell lung cancer (NSCLC) whose cancer is no longer responding to prior immunotherapy.

The study will compare:

N‑803 plus tislelizumab and docetaxel (the experimental treatment)
versus
Docetaxel alone (the standard treatment)

Participants will be randomly assigned to a treatment group. For every 3 people who join the study, 2 will receive the experimental treatment and 1 will receive docetaxel alone. This helps ensure the results are fair and unbiased.

To keep the groups balanced, randomization will consider:

Geographic region: North America, Europe, Asia, or Other
Type of NSCLC: squamous or non‑squamous
Presence of certain gene changes (actionable genomic alterations):
- EGFR, ALK, or ROS1
- Other actionable alterations
- No actionable alterations