Immunotherapy without chemotherapy for first-line advanced NSCLC with high PD-L1

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial investigates anti-PD-1 monotherapy as a first-line option for adults with advanced/metastatic NSCLC and PD-L1 TPS >50%, without EGFR/ALK/ROS1 mutations. Enrolled participants receive pembrolizumab or cemiplimab, aiming to determine short- and longer-term clinical benefits and safety. The study considers tumor biology and inflammatory status to refine patient selection and monitor outcomes. Eligibility emphasizes high PD-L1 expression and an inflamed tumor microenvironment, with careful exclusion of prior PD-(L)1/CTLA-4/LAG-3/TIM-3 therapy and certain comorbid conditions. Results will inform whether chemotherapy can be omitted in this biomarker-selected subpopulation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institut Gustave Roussy
  Villejuif, France Recruiting
• Institut Bergonie Bordeaux
  Bordeaux, France Not yet recruiting
• APHP-Hôpital Ambroise Paré
  Boulogne-Billancourt, France Not yet recruiting
• Centre Antoine Lacassagne
  Nice, France Not yet recruiting

Study contacts

• Principal investigator: David PLANCHARD, MD, PHD — Gustave Roussy, Cancer Campus, Grand Paris
• Study coordinator: Priyanka DEVI-MARULKAR, PhD, MBA
• Email: p-devi-marulkar@unicancer.fr
• Phone: +33 (0) 06 62 53 60 43

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.