ClinicaliQ Trial Snapshot
- 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 — Recruiting • Phase III • Oncology….
- What is being tested: A phase 3 randomized trial comparing two experimental combination regimens (N-803 plus tislelizumab with docetaxel, or prior failed PD-1/PD-L1 checkpoint inhibitor with docetaxel) against docetaxel monotherapy in patients with advanced/metastatic NSCLC who have developed resistance to initial immunotherapy.
- Patient eligibility overview: The trial enrolls patients with advanced or metastatic non-small cell lung cancer who have acquired resistance to immune checkpoint inhibitors, making this a second-line or later treatment population with prior failed PD-1/PD-L1 therapy.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
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…
Eligibility Snapshot
- Eligibility Criteria: Women and men of all races and ethnic groups are eligible for this trial. Cohort A Inclusion Criteria: 1. Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. Pathologically confirmed stage IV NSCLC disease. 4. Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately following an initial response (of any duration) or stable disease (approximately 6 months duration [± 2 weeks]). Participants who received anti-PD-1/anti-PD-L1 mAb as first-line therapy may have received the combination of platinum-based chemotherapy and anti-PD-1/anti-PD-L1 mAb in the second line. Participants must have received platinum chemotherapy to be eligible. Participants must have received anti-PD-1/anti-PD-L1 mAb in their immediate prior line of therapy to be eligible.
- Participants with AGA must have 1 or more documented AGA(s): EGFR, ROS1, neurotrophic tyrosine receptor kinase (NTRK), B rapidly accelerated fibrosarcoma (BRAF), mesenchymal epithelial transition (MET) exon 14 skipping, rearranged during transfection (RET), Kirsten Rat sarcoma (KRAS) and HER2.
- Participants with AGA must meet the following criteria for advanced or metastatic NSCLC. Participants who have been treated with…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.