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Study of Rilvegostomig or Pembrolizumab for Lung Cancer

This study is looking at two treatments, rilvegostomig and pembrolizumab, for people with metastatic non-small cell lung cancer (mNSCLC). Metastatic means the cancer has spread. You might be able to join if your cancer has a high level of a specific protein called PD-L1. The study aims to see how well rilvegostomig works compared to pembrolizumab in improving how long people live (Overall Survival) and how long they live without the cancer getting worse (Progression-Free Survival). These outcomes will be tracked for up to 5 years. The study is currently recruiting 830 participants.

Study design
This is a Phase III study where participants are randomly assigned to receive either rilvegostomig or pembrolizumab. It is a double-blind study, meaning neither you nor your doctor will know which treatment you are receiving.
What's involved
You would receive either rilvegostomig or pembrolizumab intravenously (through a vein) on Day 1 of each 21-day cycle.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for up to approximately 5 years to measure overall survival and progression-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06868277

A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~830 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:RilvegostomigPembrolizumab

At a glance

Recruiting sites
247 of 304 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over Up to approximately 5 years
+1 more outcome measured

Conditions

Carcinoma, Non-Small Cell Lung

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

304 sites across 49 states
China42
Germany28
Japan25
Spain16
Brazil15
France14
Italy13
Portugal11

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically or cytologically documented NSCLC (non small lung cancer), including all histological subtypes.
Stage IV mNSCLC (metastatic non-small cell lung cancer) (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements. Negative assay result is required for all non-squamous histology subtypes.
Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L (first line) therapies.
WHO (World Health Organization)/ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.
Minimum life expectancy of 12 weeks.
Provision of acceptable tumor sample for the central testing prior to randomization.
At least one lesion not previously irradiated that qualifies as a RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1) TL (target lesion) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT (computed tomography) or MRI (magnetic resonance imaging) and is suitable for accurate repeated measurements.
Adequate organ and bone marrow function

Exclusion

As judged by the investigator, any severe or uncontrolled systemic diseases, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
History of organ transplant.
Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
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.
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.
Active primary immunodeficiency/active infectious disease(s)
Active tuberculosis infection
Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small cell lung cancer).
Any prior exposure to an anti-TIGIT (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
Any prior treatment with an anti-PD-1 (programmed cell death protein 1) or anti-PD-L1 (anti-programmed death-ligand 1) agent.

What this trial measures

  • Overall Survival (OS)Up to approximately 5 years

    OS is defined as the time from randomization until the date of death due to any cause.

  • Progression-Free Survival (PFS)Up to approximately 5 years

    PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression).