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Phase III Study for Squamous Non-Small Cell Lung Cancer

This study is testing two different treatment approaches for locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) that has spread or cannot be removed by surgery. You might be eligible if you have this type of lung cancer and your tumor shows a certain level of PD-L1 (a protein on cancer cells). The study compares rilvegostomig plus chemotherapy (carboplatin and paclitaxel or nab-paclitaxel) to pembrolizumab plus the same chemotherapy. Researchers want to see if one combination helps people live longer or prevents the cancer from growing for a longer time. This is a large study with 1160 planned participants.

Study design
This is a Phase III, randomized, double-blind study comparing two treatment combinations. It will involve 1160 participants globally.
What's involved
Rilvegostomig, pembrolizumab, carboplatin, paclitaxel, or nab-paclitaxel are given intravenously (IV) on specific days of a 21-day cycle. Chemotherapy is given for up to 4 cycles.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for overall survival and progression-free survival for up to approximately 6 years.

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

NCT06692738

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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~1,160 participants
Updated 2026-09-18 on ClinicalTrials.gov
What's tested:RilvegostomigPembrolizumabCarboplatinPaclitaxelNab-paclitaxel

At a glance

Recruiting sites
266 of 328 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over Up to approximately 6 years
+1 more outcome measured

Conditions

Non-small Cell Lung Cancer

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NCT06692738

Where you'd take part

This study runs at 328 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Research Site

    Tucson, Arizonano site contact published

    Recruiting

  • Research Site

    Springdale, Arkansasno site contact published

    Recruiting

  • Research Site

    Anaheim, Californiano site contact published

    Recruiting

  • Research Site

    Beverly Hills, Californiano site contact published

    Recruiting

  • Research Site

    Loma Linda, Californiano site contact published

    Recruiting

  • Research Site

    Los Alamitos, Californiano site contact published

    Recruiting

  • Research Site

    Redlands, Californiano site contact published

    Recruiting

  • Research Site

    San Francisco, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

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

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Histologically or cytologically documented squamous NSCLC.
Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) 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 and available targeted 1L therapies.
Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC ≥ 1%.
At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL 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 or MRI and is suitable for accurate repeated measurements.
Adequate organ and bone marrow function.

Exclusion

Presence of small cell and neuroendocrine histology components.
Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
Any prior systemic, non-curative therapy received for NSCLC.
Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
Any prior exposure to an 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 systemic treatment with the use of disease-modifying agents or other immunosuppressive drugs.
Active primary immunodeficiency/active infectious disease(s).
Active tuberculosis infection.

What this trial measures

  • Overall survival (OS)Up to approximately 6 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 6 years

    PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).