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

RecruitingPhase 2Ages 18 Years - anyAllUNICANCER
NCT07360743 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 durable responses with immunotherapy alone, highlighting the potential of immune checkpoint inhibition to provide long-term clinical benefit without the toxicities associated with cytotoxic chemotherapy. Despite these successes, accumulating clinical evidence has revealed a clinically significant ri

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📋 Eligibility rules (as published)
Inclusion Criteria: In addition to the inclusion criteria of the METAREM master protocol, following additional criteria must be respected during patient inclusion in META-1 trial: 1. Patients with age ≥18 years 2. Patients in first-line therapy for advanced metastatic NSCLC with PD-L1 Tumor Proportion Score (TPS) \>50%, without EGFR/ ALK/ ROS1 mutations and irrespective of their histological subtype (squamous or non-squamous). 3. 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 followed up to 36 months or death according to standard of care. Exclusion Criteria: In addition to the Exclusion criteria of the METAREM master protocol, following additional criteria must be considered during patient exclusion from META-1 trial: 1. Patients who have previously received an anti-PD(L)1 or anti-CTLA4 or anti-LAG-3 or anti-TIM3 immunotherapy. 2. Patients with any Hypersensitivity to the active ingredient or to any of the excipients of Pembrolizumab or Cemiplimab.
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What it tests

  • Pembrolizumab
  • Cemiplimab
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Where

4 sites
Institut Bergonie Bordeaux
Bordeaux, France
APHP-Hôpital Ambroise Paré
Boulogne-Billancourt, France
Centre Antoine Lacassagne
Nice, France
Institut Gustave Roussy
Villejuif, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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