Immunotherapy Without Chemotherapy for Advanced Lung Cancer Patients With High PD-L1 Levels

Anti-PD-1 monotherapy has demonstrated significant clinical efficacy in advanced or metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression (tumor proportion score \[TPS\] \>50%), outperforming platinum-based chemotherapy in terms of objective response rate (ORR) and overall survival (OS). Pivotal randomized trials such as KEYNOTE-024 and EMPOWER-Lung 1 established the superiority of PD-1 blockade in this patient population, leading to regulatory approvals by both the FDA and EMA for first-line treatment. These studies confirmed that a subset of patients can achieve deep and d

Trial Details

NCT ID
NCT07360743
Phase
PHASE2
Sponsor
UNICANCER
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Pembrolizumab
  • Cemiplimab
Locations (sample)
  • Bordeaux, France|44.84124,-0.58046
  • Boulogne-Billancourt, France|48.83545,2.24128
  • Nice, France|43.70313,7.26608
  • Villejuif, France|48.7939,2.35992

Key Eligibility Criteria

  • In addition to the inclusion criteria of the METAREM master protocol, following additional criteria must be respected during patient inclusion in M…
  • Patients with age ≥18 years
  • Patients in first-line therapy for advanced metastatic NSCLC with PD-L1 Tumor Proportion Score (TPS) \>50%, without EGFR/ ALK/ ROS1 mutations and i…
  • Patients with a PTI score of zero in plasma on the baseline PORTRAIT report. Note: Patients with PTI score ≥ 1 who meet all other criteria will be …

For full eligibility, visit ClinicalTrials.gov.

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