Actively Recruiting
A Phase III, Randomized, Double-blind, Global Study of Rilvegostomig or Pembrolizumab with Platinum-based Chemotherapy for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer Expressing PD-L1
Led by AstraZeneca · Updated on 2026-05-01
880
Participants Needed
301
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with the same chemotherapy for first-line treatment of patients with metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1 at 1 or higher. This Phase III, randomized, double-blind, global study focuses on patients with squamous mNSCLC without actionable genomic mutations and assesses these treatments over approximately five years. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle, combined with carboplatin and paclitaxel or nab-paclitaxel chemotherapy. Chemotherapy is given up to 4 cycles, with nab-paclitaxel administered on Days 1, 8, and 15 of each cycle. After chemotherapy, patients continue with the assigned immunotherapy drug. The study compares these two treatment regimens as first-line therapy. During the study, participants undergo regular assessments including imaging to measure tumor response, survival, and disease progression up to about five years. Researchers also monitor physical functioning, quality of life, lung cancer symptoms, and drug pharmacokinetics and immunogenicity. Safety is closely followed, and overall survival and progression-free survival are the primary outcomes measured to evaluate the treatments impact.
CONDITIONS
Brief Title
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed squamous non-small cell lung cancer
- Stage IV metastatic non-small cell lung cancer not suitable for curative treatment
- No actionable genomic mutations for which approved targeted first-line therapies exist
- Tumor PD-L1 expression of 1% or higher confirmed by acceptable tumor sample
- At least one measurable lesion not previously irradiated suitable for repeated measurement
- Adequate organ and bone marrow function
You will not qualify if you...
- Presence of small cell or neuroendocrine tumor components
- Brain metastases unless asymptomatic, stable, and off steroids or anticonvulsants for at least 7 days before randomization
- Prior systemic therapy for advanced or metastatic non-small cell lung cancer
- Prior treatment with anti-PD-1, anti-PD-L1, anti-TIGIT, or similar immune therapies
- History of other primary cancers unless treated with curative intent and no active disease for at least 2 years
- Active or prior autoimmune or inflammatory disorders requiring chronic immunosuppressive treatment
- Active primary immunodeficiency or infectious diseases
- Active tuberculosis infection
Research Team
A
AstraZeneca Clinical Study Information Center
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