RECRUITING Phase 3 ClinicalTrials.gov

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)

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT06692738

Registry updated: 2026-09-18

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Description

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

Interventions

Rilvegostomig (Drug)
Administered intravenously (IV) on Day 1 of each 21-day cycle
Pembrolizumab (Drug)
Administered intravenously (IV) on Day 1 of each 21-day cycle
Carboplatin (Drug)
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Paclitaxel (Drug)
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Nab-paclitaxel (Drug)
Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles

Eligibility criteria

Inclusion Criteria: * 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 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, 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.

Conditions

Non-small Cell Lung Cancer

Locations

Research Site — Tucson, Arizona, United States
Research Site — Springdale, Arkansas, United States
Research Site — Anaheim, California, United States
Research Site — Beverly Hills, California, United States
Research Site — Loma Linda, California, United States
Research Site — Los Alamitos, California, United States
Research Site — Redlands, California, United States
Research Site — San Francisco, California, United States
Research Site — Walnut Creek, California, United States
Research Site — West Haven, Connecticut, United States
Research Site — Newark, Delaware, United States
Research Site — Bay Pines, Florida, United States
Research Site — Fort Lauderdale, Florida, United States
Research Site — Gainesville, Florida, United States
Research Site — Gainesville, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Athens, Georgia, United States
Research Site — Atlanta, Georgia, United States
Research Site — Savannah, Georgia, United States
Research Site — Boise, Idaho, United States
Research Site — Chicago, Illinois, United States
Research Site — Decatur, Illinois, United States
Research Site — Hinsdale, Illinois, United States
Research Site — Quincy, Illinois, United States
Research Site — Rockford, Illinois, United States
Research Site — Fort Wayne, Indiana, United States
Research Site — Waterloo, Iowa, United States
Research Site — Lexington, Kentucky, United States
Research Site — Lexington, Kentucky, United States
Research Site — Louisville, Kentucky, United States
Research Site — Louisville, Kentucky, United States
Research Site — Alexandria, Louisiana, United States
Research Site — Baton Rouge, Louisiana, United States
Research Site — Covington, Louisiana, United States
Research Site — Shreveport, Louisiana, United States
Research Site — Shreveport, Louisiana, United States
Research Site — Scarborough, Maine, United States
Research Site — Baltimore, Maryland, United States
Research Site — Bethesda, Maryland, United States
Research Site — Bethesda, Maryland, United States
Research Site — Detroit, Michigan, United States
Research Site — Grand Rapids, Michigan, United States
Research Site — Saginaw, Michigan, United States
Research Site — Duluth, Minnesota, United States
Research Site — Rochester, Minnesota, United States
Research Site — Bridgeton, Missouri, United States
Research Site — Columbia, Missouri, United States
Research Site — Kansas City, Missouri, United States
Research Site — Lincoln, Nebraska, United States
Research Site — Camden, New Jersey, United States
Research Site — Buffalo, New York, United States
Research Site — East Syracuse, New York, United States
Research Site — Westbury, New York, United States
Research Site — Wilson, North Carolina, United States
Research Site — Grand Forks, North Dakota, United States
Research Site — Cincinnati, Ohio, United States
Research Site — Bend, Oregon, United States
Research Site — Medford, Oregon, United States
Research Site — Salem, Oregon, United States
Research Site — Hershey, Pennsylvania, United States
Research Site — York, Pennsylvania, United States
Research Site — Sioux Falls, South Dakota, United States
Research Site — Chattanooga, Tennessee, United States
Research Site — Nashville, Tennessee, United States
Research Site — Fort Worth, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Kingwood, Texas, United States
Research Site — Lubbock, Texas, United States
Research Site — Round Rock, Texas, United States
Research Site — Fairfax, Virginia, United States
Research Site — Fredericksburg, Virginia, United States
Research Site — Olympia, Washington, United States
Research Site — Seattle, Washington, United States
Research Site — Silverdale, Washington, United States
Research Site — Spokane, Washington, United States
Research Site — Tacoma, Washington, United States
Research Site — Wenatchee, Washington, United States
Research Site — Buenos Aires, Argentina
Research Site — CABA, Argentina
Research Site — La Plata, Argentina
Research Site — Pilar, Argentina
Research Site — Rosario, Argentina
Research Site — Darlinghurst, Australia
Research Site — Hyde Park, Australia
Research Site — Southport, Australia
Research Site — Wollongong, Australia
Research Site — Innsbruck, Austria
Research Site — Krems, Austria
Research Site — Rankweil, Austria
Research Site — Vienna, Austria
Research Site — Vienna, Austria
Research Site — Anderlecht, Belgium
Research Site — Brussels, Belgium
Research Site — Charleroi, Belgium
Research Site — Kortrijk, Belgium
Research Site — Ottignies, Belgium
Research Site — Sint-Niklaas, Belgium
Research Site — Barretos, Brazil
Research Site — Florianópolis, Brazil
Research Site — Ijuí, Brazil
Research Site — Londrina, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Salvador, Brazil
Research Site — São Paulo, Brazil
Research Site — São Paulo, Brazil
Research Site — Taubaté, Brazil
Research Site — Saint John, New Brunswick, Canada
Research Site — Sydney, Nova Scotia, Canada
Research Site — Greater Sudbury, Ontario, Canada
Research Site — Hamilton, Ontario, Canada
Research Site — Sault Ste. Marie, Ontario, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Changchun, China
Research Site — Changde, China
Research Site — Changsha, China
Research Site — Chengdu, China
Research Site — Chengdu, China
Research Site — Chongqing, China
Research Site — Dalian, China
Research Site — Guangzhou, China
Research Site — Guangzhou, China
Research Site — Hangzhou, China
Research Site — Hangzhou, China
Research Site — Hangzhou, China
Research Site — Harbin, China
Research Site — Hefei, China
Research Site — Hefei, China
Research Site — Jinan, China
Research Site — Kunming, China
Research Site — Linhai, China
Research Site — Linyi, China
Research Site — Nanchang, China
Research Site — Ningbo, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shenyang, China
Research Site — Shenzhen, China
Research Site — Taiyuan, China
Research Site — Tianjin, China
Research Site — Wenzhou, China
Research Site — Wuhan, China
Research Site — Xi'an, China
Research Site — Yangzhou, China
Research Site — Yueyang, China
Research Site — Zhengzhou, China
Research Site — Zhengzhou, China
Research Site — Avignon, France
Research Site — La Rochelle, France
Research Site — Lyon, France
Research Site — Nîmes, France
Research Site — Rennes, France
Research Site — Strasbourg, France
Research Site — Suresnes, France
Research Site — Toulon, France
Research Site — Bad Berka, Germany
Research Site — Berlin, Germany
Research Site — Berlin, Germany
Research Site — Bielefeld, Germany
Research Site — Bochum, Germany
Research Site — Chemnitz, Germany
Research Site — Cologne, Germany
Research Site — Essen, Germany
Research Site — Esslingen am Neckar, Germany
Research Site — Frankfurt, Germany
Research Site — Frankfurt am Main, Germany
Research Site — Gauting, Germany
Research Site — Giessen, Germany
Research Site — Großhansdorf, Germany
Research Site — Halle, Germany
Research Site — Hamburg, Germany
Research Site — Hanover, Germany
Research Site — Hanover, Germany
Research Site — Heidelberg, Germany
Research Site — Hemer, Germany
Research Site — Homburg, Germany
Research Site — Kassel, Germany
Research Site — Kiel, Germany
Research Site — Krefeld, Germany
Research Site — Magdeburg, Germany
Research Site — Minden, Germany
Research Site — Moers, Germany
Research Site — München, Germany
Research Site — Regensburg, Germany
Research Site — Schwerin, Germany
Research Site — Velbert, Germany
Research Site — Würzburg, Germany
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Debrecen, Hungary
Research Site — Edelény, Hungary
Research Site — Gyöngyös, Hungary
Research Site — Gyöngyös - Mátraháza, Hungary
Research Site — Győr, Hungary
Research Site — Pécs, Hungary
Research Site — Székesfehérvár, Hungary
Research Site — Törökbálint, Hungary
Research Site — Calicut, India
Research Site — Delhi, India
Research Site — Gūrgaon, India
Research Site — Kolkata, India
Research Site — Madurai, India
Research Site — Mumbai, India
Research Site — Nashik, India
Research Site — New Delhi, India
Research Site — Puducherry, India
Research Site — Surat, India
Research Site — Varanasi, India
Research Site — Florence, Italy
Research Site — Legnano, Italy
Research Site — Livorno, Italy
Research Site — Monza, Italy
Research Site — Orbassano, Italy
Research Site — Padova, Italy
Research Site — Peschiera del Garda, Italy
Research Site — Roma, Italy
Research Site — Amagasaki-shi, Japan
Research Site — Bunkyō City, Japan
Research Site — Chūōku, Japan
Research Site — Fukuoka, Japan
Research Site — Fukuoka, Japan
Research Site — Hirakata-shi, Japan
Research Site — Hiroshima, Japan
Research Site — Kakogawa-shi, Japan
Research Site — Kanazawa, Japan
Research Site — Kawagoe-shi, Japan
Research Site — Kawasaki-shi, Japan
Research Site — Kitaadachi-gun, Japan
Research Site — Kitakyushu-shi, Japan
Research Site — Kiyose-shi, Japan
Research Site — Kobe, Japan
Research Site — Kōtoku, Japan
Research Site — Kumamoto, Japan
Research Site — Kumamoto, Japan
Research Site — Kyoto, Japan
Research Site — Matsusaka-shi, Japan
Research Site — Obihiro-shi, Japan
Research Site — Osaka, Japan
Research Site — Ota-shi, Japan
Research Site — Saitama-shi, Japan
Research Site — Sakai, Japan
Research Site — Sapporo, Japan
Research Site — Sendai, Japan
Research Site — Shinjuku-ku, Japan
Research Site — Takaoka-shi, Japan
Research Site — Yokohama, Japan
Research Site — Yokohama, Japan
Research Site — George Town, Malaysia
Research Site — Johor Bahru, Malaysia
Research Site — Kuala Lumpur, Malaysia
Research Site — Alkmaar, Netherlands
Research Site — Ede, Netherlands
Research Site — Groningen, Netherlands
Research Site — Leidschendam, Netherlands
Research Site — Veldhoven, Netherlands
Research Site — Zwolle, Netherlands
Research Site — Lima, Peru
Research Site — Lima, Peru
Research Site — Lima, Peru
Research Site — Lima, Peru
Research Site — Lima, Peru
Research Site — Lima, Peru
Research Site — Bialystok, Poland
Research Site — Biała Podlaska, Poland
Research Site — Bydgoszcz, Poland
Research Site — Bystra, Poland
Research Site — Lodz, Poland
Research Site — Lublin, Poland
Research Site — Poznan, Poland
Research Site — Warsaw, Poland
Research Site — Wroclaw, Poland
Research Site — San Juan, Puerto Rico
Research Site — San Juan, Puerto Rico
Research Site — Changwon-si, South Korea
Research Site — Cheongju-si, South Korea
Research Site — Incheon, South Korea
Research Site — JinJoo, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Suwon, South Korea
Research Site — Suwon, South Korea
Research Site — Barcelona, Spain
Research Site — Las Palmas de Gran Canaria, Spain
Research Site — Lleida, Spain
Research Site — Madrid, Spain
Research Site — Madrid, Spain
Research Site — Majadahonda, Spain
Research Site — Seville, Spain
Research Site — Kaohsiung City, Taiwan
Research Site — Kaohsiung City, Taiwan
Research Site — New Taipei City, Taiwan
Research Site — New Taipei City, Taiwan
Research Site — Taichung, Taiwan
Research Site — Taichung, Taiwan
Research Site — Tainan, Taiwan
Research Site — Taoyuan, Taiwan
Research Site — Bangkok, Thailand
Research Site — Chiang Mai, Thailand
Research Site — Dusit, Thailand
Research Site — Nakhon Ratchasima, Thailand
Research Site — Songkhla, Thailand
Research Site — Ankara, Turkey (Türkiye)
Research Site — Antalya, Turkey (Türkiye)
Research Site — Istanbul, Turkey (Türkiye)
Research Site — Yenimahalle, Turkey (Türkiye)
Research Site — Aberdeen, United Kingdom
Research Site — Cambridge, United Kingdom
Research Site — Edinburgh, United Kingdom
Research Site — Exeter, United Kingdom
Research Site — Greater London, United Kingdom
Research Site — London, United Kingdom
Research Site — London, United Kingdom
Research Site — Manchester, United Kingdom
Research Site — Newcastle upon Tyne, United Kingdom
Research Site — Preston, United Kingdom
Research Site — Can Tho, Vietnam
Research Site — Hanoi, Vietnam
Research Site — Ho Chi Minh City, Vietnam
Research Site — Vinh, Vietnam

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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