Actively Recruiting
A Phase III, Randomized, Double-blind, Global Study of Rilvegostomig or Pembrolizumab With Platinum-based Chemotherapy for First-line Treatment of Metastatic Non-squamous Non-small Cell Lung Cancer Expressing PD-L1
Led by AstraZeneca · Updated on 2026-05-22
878
Participants Needed
283
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of two treatments, rilvegostomig and pembrolizumab, each combined with platinum-based doublet chemotherapy, as first-line therapy for patients with metastatic non-squamous non-small cell lung cancer mNSCLC whose tumors express PD-L1. The study is a Phase III, randomized, double-blind trial conducted globally at multiple centers. It focuses on patients with tumors expressing PD-L1 at 1 or higher and aims to compare these treatment combinations in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group receives rilvegostomig intravenously on Day 1 of each 21-day cycle, combined with platinum-based chemotherapy carboplatin or cisplatin and pemetrexed, followed by maintenance rilvegostomig plus pemetrexed monotherapy. The other group receives pembrolizumab intravenously on the same schedule with the same chemotherapy drugs, followed by pembrolizumab plus pemetrexed maintenance. Chemotherapy is given for up to four cycles. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately five years. Researchers will also assess response rates, duration of response, pharmacokinetics, immunogenicity, and patient-reported physical function and quality of life. Safety will be carefully tracked throughout the study. The trial began in late 2024 and is expected to conclude around March 2030.
CONDITIONS
Brief Title
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer.
- Stage IV metastatic non-small cell lung cancer not suitable for curative treatment.
- No sensitizing EGFR mutations or ALK and ROS1 rearrangements.
- No actionable driver oncogenes with approved targeted first-line therapies.
- Tumor PD-L1 expression with tumor cells ≥ 1%.
- At least one measurable lesion ≥ 10 mm (or lymph node ≥ 15 mm) not previously irradiated.
- Adequate organ and bone marrow function.
You will not qualify if you...
- Presence of small cell or neuroendocrine histology components.
- Brain metastases unless asymptomatic, stable, and off steroids or anticonvulsants for at least 7 days prior to randomization.
- Less than 2 weeks since brain radiotherapy or surgery with recovery from acute effects.
- Prior systemic therapy for advanced or metastatic non-small cell lung cancer.
- Prior exposure to anti-TIGIT therapy or other immune-regulatory anticancer therapies.
- Prior treatment with anti-PD-1 or anti-PD-L1 agents.
- History of other primary malignancies 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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