Last updated 16 days ago
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
880 patients around the world
Available in Peru, Brazil, Argentina
This is a Phase III, two-arm, randomized, double-blind, global, multicenter study
assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in
combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for
patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors
express PD-L1 (tumor cells (TC) ≥ 1%).
AstraZeneca
880Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically or cytologically documented squamous non-small cell lung cancer (NSCLC).Stage IV metastatic non-small cell lung cancer (mNSCLC) not amenable to curative treatment.Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved targeted first-line (1L) therapies.Provision of acceptable tumor sample to confirm tumor programmed death-ligand 1 (PD-L1) expression tumor cells (TC) ≥ 1%.At least one lesion not previously irradiated that qualifies as a Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) target lesion (TL) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.Adequate organ and bone marrow function.
- Presence of small cell and neuroendocrine histology components.Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment. Participants must have recovered from the acute toxic effect of radiotherapy.Any prior systemic therapy received for advanced or metastatic non-small cell lung cancer (mNSCLC).Prior treatment with an anti-programmed cell death protein 1 (anti-PD-1) or anti-programmed death-ligand 1 (anti-PD-L1) agent.Any prior exposure to an anti-T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (anti-TIGIT) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.Active primary immunodeficiency/active infectious disease(s).Active tuberculosis infection.
SponsorAstraZeneca
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06692738
