Actively Recruiting
Global Phase III Trial Comparing Rilvegostomig or Pembrolizumab Plus Platinum Chemotherapy for First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer with PD-L1 Expression
Led by AstraZeneca · Updated on 2026-07-14
1160
Participants Needed
312
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or 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 III B/C or IV locally advanced or metastatic disease not suitable for curative treatment
- No actionable genomic mutations with approved targeted first-line therapies
- Tumor PD-L1 expression of at least 1% confirmed by acceptable tumor sample
- At least one measurable lesion not previously irradiated suitable for repeated imaging measurements
- 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
- Less than 2 weeks since last brain radiotherapy or surgery with recovery from acute effects
- Prior systemic non-curative therapy for non-small cell lung cancer
- Previous treatment with anti-PD-1, anti-PD-L1, anti-TIGIT, or other immune-targeting anticancer therapies
- History of other primary malignancies unless disease free for at least 2 years and low recurrence risk
- Active or prior autoimmune or inflammatory disorders requiring chronic immunosuppressive treatment
- Active primary immunodeficiency or infectious diseases including active tuberculosis
Research Team
A
AstraZeneca Clinical Study Information Center
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