Comparing Rilvegostomig and Pembrolizumab with Chemotherapy for Lung Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global Phase III study evaluates the efficacy and safety of rilvegostomig versus pembrolizumab, both combined with platinum-based chemotherapy, as first-line treatments for patients with metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors express PD-L1. The study is randomized and double-blind, ensuring unbiased results. Participants will be monitored for treatment response and safety throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically documented non-squamous NSCLC.
* Stage III B/C or IV NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
* Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
* 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 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 Criteria:

* 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 therapy received for NSCLC except in the neoadjuvant or adjuvant setting or definitive chemoradiotherapy with the intent to cure, provided that progression has occurred \> 12 months after the end of systemic therapy treatment.
* Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
* Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
* 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, corticosteroids, or immunosuppressive drugs.
* Active primary immunodeficiency/active infectious disease(s).
* Active tuberculosis infection.

Where it's running

• Research Site
  Mobile, Alabama, United States Recruiting
• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  Anaheim, California, United States Recruiting
• Research Site
  Beverly Hills, California, United States Recruiting
• Research Site
  Loma Linda, California, United States Recruiting
• Research Site
  Redlands, California, United States Recruiting

+251 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• First-line treatment with pembrolizumab, pemetrexed, and platinum with or without zoldonrasib for metastatic non-squamous NSCLC

  This trial tests whether adding zoldonrasib to standard pembrolizumab and platinum chemotherapy helps people with untreated metastatic non-squamous NSCLC that has a RAS G12D mutation.

  Recruiting at 4 sites Phase 3 Revolution Medicines, Inc. · Anchorage, Alaska and 3 other locations · NCT07777822

• Aglatimagene Besadenovec with Prodrug and Pembrolizumab vs Docetaxel for Advanced Non-Squamous NSCLC

  This phase 3 trial tests whether giving aglatimagene besadenovec with a prodrug and pembrolizumab works better than standard chemotherapy (docetaxel) for adults with stage IV non-squamous NSCLC that progressed on pembrolizumab.

  Recruiting Phase 3 Candel Therapeutics, Inc. · New York, New York · NCT07660094

• BL-M07D1 plus pembrolizumab for advanced HER2‑overexpressing non-squamous NSCLC

  This treatment combines BL-M07D1 with pembrolizumab to see if it helps people with unresectable locally advanced or metastatic HER2‑overexpressing non‑squamous non‑small cell lung cancer.

  Recruiting Phase 2 Sichuan Baili Pharmaceutical Co., Ltd. · Wuhan, Hubei · NCT07264816

• Lenvatinib and Pembrolizumab With or Without SBRT for Metastatic Kidney Cancer

  This study tests whether adding SBRT to standard lenvatinib plus pembrolizumab helps people with metastatic kidney cancer who have stable disease after initial treatment.

  Recruiting at 8 sites Phase 2 Kidney Cancer Research Bureau · Kazan' and 7 other locations · NCT07928167

• KRAS Inhibitor ETX-929 in advanced solid tumors

  This trial tests ETX-929, alone or with cetuximab, in people whose cancers have KRAS mutations and have progressed after prior therapy.

  Recruiting Phase 1/2 Ensem Therapeutics · Fairfax, Virginia · NCT07912593

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.