New lung cancer drug rilvegostomig takes on keytruda in global showdown

NCT ID NCT06868277

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 04, 2026 · Updated 4 times

Summary

This phase 3 study compares a new biologic drug, rilvegostomig, to the standard drug pembrolizumab (Keytruda) as a first treatment for people with advanced non-small cell lung cancer that has high PD-L1 levels. About 830 participants worldwide will receive either drug by IV every three weeks. The main goals are to see if rilvegostomig helps people live longer or keeps cancer from growing longer than pembrolizumab.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: rilvegostomig (a biologic drug given by IV)
What this could lead to: If rilvegostomig works better than pembrolizumab, it could become a new first-line treatment option for people with advanced lung cancer that has high PD-L1 levels.
What could go wrong: This is a large phase 3 trial, but it's still experimental. Rilvegostomig may not prove superior to the existing standard (pembrolizumab), and side effects are possible. Results will take years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 830 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

302 sites in 26 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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La Mesa, California, 91942, United States
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Los Alamitos, California, 90720, United States
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Newark, Delaware, 19713, United States
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Bay Pines, Florida, 33744, United States
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Clearwater, Florida, 33756, United States
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Gainesville, Florida, 32610, United States
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St. Petersburg, Florida, 33705, United States
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Marietta, Georgia, 30060, United States
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Chicago, Illinois, 60612, United States
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Decatur, Illinois, 62526, United States
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Des Moines, Iowa, 50309, United States
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Waterloo, Iowa, 50702, United States
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Leawood, Kansas, 66209, United States
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Lexington, Kentucky, 40536, United States
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Owensboro, Kentucky, 42303, United States
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Bethesda, Maryland, 20817, United States
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Frederick, Maryland, 21702, United States
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Silver Spring, Maryland, 20910, United States
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Towson, Maryland, 21204, United States
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Saginaw, Michigan, 48602, United States
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Bridgeton, Missouri, 63044, United States
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Lincoln, Nebraska, 68506, United States
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Reno, Nevada, 89511, United States
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Paramus, New Jersey, 07652, United States
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Buffalo, New York, 14215, United States
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East Syracuse, New York, 13057, United States
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Fresh Meadows, New York, 11366, United States
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Rochester, New York, 14642, United States
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Westbury, New York, 11590, United States
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Canton, Ohio, 44718, United States
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Fountain Hill, Pennsylvania, 18015, United States
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Kittanning, Pennsylvania, 16201, United States
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Philadelphia, Pennsylvania, 19104, United States
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Round Rock, Texas, 78665, United States
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Aberdeen, Washington, 98520, United States
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Renton, Washington, 98055, United States
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Charleston, West Virginia, 25304, United States
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Morgantown, West Virginia, 26506, United States
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Schofield, Wisconsin, 54476, United States
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CABA, 1425, Argentina
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Córdoba, 5000, Argentina
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Pilar, B1629AHJ, Argentina
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Rosario, 2000, Argentina
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Rosario, S2000CVB, Argentina
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Viedma, R8500ACE, Argentina
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Hobart, 7000, Australia
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Woolloongabba, 4102, Australia
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Edegem, 2650, Belgium
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Jette, 1090, Belgium
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Libramont-Chevigny, 6800, Belgium
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Liège, 4000, Belgium
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Mechelen, 2800, Belgium
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Roeselaere, 8800, Belgium
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Blumenau, 89010-340, Brazil
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Fortaleza, 60336-550, Brazil
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Ijuí, 98700-000, Brazil
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Itajaí, 88301-220, Brazil
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Londrina, 86015-520, Brazil
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Passo Fundo, 99010-260, Brazil
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Porto Alegre, 90035-903, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Velho, 76834-899, Brazil
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Salvador, 41253-190, Brazil
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Salvador, 41950-640, Brazil
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Santo André, 09060-650, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 04501-000, Brazil
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Teresina, 64049-200, Brazil
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Burgas, 8000, Bulgaria
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Panagyurishte, 4500, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1618, Bulgaria
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Sofia, 1756, Bulgaria
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Varna, 9010, Bulgaria
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Edmonton, Alberta, T6G 1Z2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Cambridge, Ontario, N1R 3G2, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Québec, Quebec, G1V 4G5, Canada
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Saint-Jérôme, Quebec, J7Z 5T3, Canada
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Conception, 4070196, Chile
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Santiago, 7500653, Chile
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Santiago, 7500713, Chile
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Santiago, 8420383, Chile
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Baoding, 071000, China
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Beijing, 100021, China
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Beijing, 100142, China
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Beijing, 101149, China
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Bengbu, 233004, China
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Changchun, 130000, China
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Changchun, 130033, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400030, China
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Chongqing, 400042, China
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Fuzhou, 350001, China
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Fuzhou, 350014, China
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Guangzhou, 510080, China
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Haerbin, 150081, China
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Hangzhou, 310022, China
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Hefei, 133500, China
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Hefei, 230022, China
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Jiamusi, 154007, China
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Jinan, 250117, China
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Langfang, 65699, China
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Lanzhou, 730050, China
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Linyi, 276001, China
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Liuzhou, 545007, China
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Nanchang, 330006, China
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Nanchang, 330029, China
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Nanjing, 210006, China
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Nanjing, 210008, China
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Nanning, 530021, China
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Ningbo, 315010, China
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Qingdao, 266071, China
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Shanghai, 200092, China
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Shenyang, 110042, China
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Shenzhen, 518116, China
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Suzhou, 215004, China
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Taiyuan, 030000, China
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Wuhan, 430030, China
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Wuhan, 430060, China
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Xuzhou, 221002, China
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Yantai, 264000, China
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Zhengzhou, 450008, China
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Cali, 760032, Colombia
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Floridablanca, 680001, Colombia
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Medellín, 050034, Colombia
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Valledupar, 200001, Colombia
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San José, 1000, Costa Rica
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San José, 10108, Costa Rica
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San José Capital, 1000, Costa Rica
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Santa Ana, 10903, Costa Rica
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Angers, 49100, France
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Avignon, 84000, France
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Boulogne-Billancourt, 92100, France
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Caen, 14000, France
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Chambéry, 73011, France
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Dijon, 21000, France
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La Tronche, 38700, France
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Limoges, 87042, France
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Nantes, 44093, France
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Paris, 75020, France
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Pau, 64046, France
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St-Malo, 35403, France
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Toulouse, 31300, France
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Tours, 37000, France
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Tbilisi, 0112, Georgia
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Tbilisi, 0159, Georgia
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Tbilisi, 160, Georgia
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Tbilisi, 177, Georgia
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Amberg, 92224, Germany
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Augsburg, by, 86156, Germany
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Bad Saarow, 15526, Germany
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Berlin, 12351, Germany
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Berlin, 13359, Germany
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Bonn, 53127, Germany
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Braunschweig, 38114, Germany
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Essen, 45147, Germany
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Flensburg, 24939, Germany
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Frankfurt am Main, 60431, Germany
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Hamburg, 21075, Germany
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Heidelberg, 69126, Germany
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Heilbronn, 74078, Germany
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Immenhausen, 34376, Germany
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Koblenz, 56073, Germany
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Leipzig, 04103, Germany
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München, 80336, Germany
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Neuss, 41462, Germany
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Offenbach, 63069, Germany
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Oldenburg, 26121, Germany
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Remscheid, 42859, Germany
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Rotenburg (Wümme), 27356, Germany
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Schweinfurt, 97421, Germany
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Trier, 54292, Germany
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Velbert, 42551, Germany
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Wuppertal, 42283, Germany
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Würselen, 52146, Germany
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Würzburg, 97080, Germany
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Athens, 115 27, Greece
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Athens, 11527, Greece
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Athens, 12462, Greece
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Larissa, 411 10, Greece
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Piraeus, 185 37, Greece
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Piraeus, 185 47, Greece
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Thessaloniki, 55236, Greece
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Thessaloniki, 56429, Greece
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Thessaloniki, 57001, Greece
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Cork, T12 DFK4, Ireland
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Dublin, D07 R2WY, Ireland
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Dublin, D08 NHY1, Ireland
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Dublin, D09 V2N0, Ireland
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Dublin, D24 NR0A, Ireland
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Dublin, DO4YN63, Ireland
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Galway, H91 YR71, Ireland
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Afula, 1834111, Israel
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Beersheba, 8410101, Israel
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Hadera, 38100, Israel
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Haifa, 34362, Israel
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Haifa, 91096, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 64239, Israel
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Tel Aviv, 69710, Israel
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Candiolo, 10060, Italy
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Lecco, 23900, Italy
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Lucca, 55100, Italy
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Meldola, 47014, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Naples, 80131, Italy
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Peschiera del Garda, 37019, Italy
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Pisa, 56126, Italy
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Roma, 00144, Italy
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Torrette Di Ancona, 60126, Italy
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Udine, 33100, Italy
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Verona, 37126, Italy
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Akashi, 673-8558, Japan
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Bunkyō City, 113-8603, Japan
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Bunkyō City, 113-8677, Japan
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Fukuoka, 811-1395, Japan
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Fukuoka, 812-8582, Japan
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Hamamatsu, 431-3192, Japan
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Iwakuni-shi, 740-8510, Japan
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Izumi-shi, 594-0073, Japan
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Kashihara-shi, 634-8522, Japan
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Kobe, 650-0046, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Kyoto, 602-8566, Japan
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Matsuyama, 791-0280, Japan
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Nankoku-shi, 783-8505, Japan
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Niigata, 951-8566, Japan
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Osaka, 534-0021, Japan
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Sakaishi, 591-8555, Japan
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Sayama, 589-8511, Japan
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Sendai, 980-0873, Japan
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Shinagawa-ku, 142-8666, Japan
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Takarazuka-shi, 665-0827, Japan
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Toon-Shi, 791-0295, Japan
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Toyoake-shi, 470-1192, Japan
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Toyonaka-shi, 560-8552, Japan
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George Town, 10350, Malaysia
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Kota Bharu, 15586, Malaysia
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Kuala Lumpur, 50586, Malaysia
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Kuala Selangor, 62250, Malaysia
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Perai, 13700, Malaysia
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Alcabideche, 2755-009, Portugal
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Braga, 4710-243, Portugal
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Coimbra, 3000-075, Portugal
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Lisbon, 1400-038, Portugal
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Lisbon, 1500-650, Portugal
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Lisbon, 1769-001, Portugal
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Loures, 2674-514, Portugal
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Matosinhos Municipality, 4454-509, Portugal
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Porto, 4100-180, Portugal
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Porto, 4200-072, Portugal
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Porto, 4200-319, Portugal
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Bucharest, 010626, Romania
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Bucharest, 013812, Romania
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Bucharest, 022328, Romania
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Bucharest, 30167, Romania
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Craiova, 200385, Romania
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Craiova, 200542, Romania
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Iași, 700106, Romania
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Otopeni, 075100, Romania
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Piteşti, 110283, Romania
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Sibiu, 550253, Romania
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Timișoara, 300239, Romania
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Jinju, 52727, South Korea
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Seoul, 135-710, South Korea
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Seoul, 5505, South Korea
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Badajoz, 06080, Spain
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Badalona, 8916, Spain
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Barcelona, 08028, Spain
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Castellon, 12002, Spain
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Granada, 18016, Spain
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Jaén, 23007, Spain
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Lugo, 27003, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28050, Spain
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Málaga, 29010, Spain
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Oviedo, 33006, Spain
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Palma de Mallorca, 07198, Spain
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Valencia, 46015, Spain
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Vigo (Pontevedra), 36312, Spain
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Zaragoza, 50009, Spain
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Lausanne, 1011, Switzerland
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Ankara, 06010, Turkey (Türkiye)
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Bakırköy, 34147, Turkey (Türkiye)
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Çankaya, 06680, Turkey (Türkiye)
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İzmit, 41380, Turkey (Türkiye)
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Küçükçekmece, 34295, Turkey (Türkiye)
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Yüreğir, 01240, Turkey (Türkiye)
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Blackpool, FY3 8NR, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Guildford, GU2 7XX, United Kingdom
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Hull, HU16 5JQ, United Kingdom
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Northwood, HA6 2RN, United Kingdom
Research Site
RECRUITING

Oxford, OX4 6LB, United Kingdom

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