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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)

NCT06692738 · AstraZeneca
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Official title
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
About this study
This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).
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.
Study design
Enrollment target: 1160 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-11-18
Estimated completion: 2030-07-01
Last updated: 2026-08-13
Interventions
Drug: RilvegostomigDrug: PembrolizumabDrug: CarboplatinDrug: PaclitaxelDrug: Nab-paclitaxel
Primary outcomes
  • Overall survival (OS) (Up to approximately 6 years)
  • Progression-free survival (PFS) (Up to approximately 6 years)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (325)
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Tucson, Arizona, United States
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Springdale, Arkansas, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Loma Linda, California, United States
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Los Alamitos, California, United States
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Redlands, California, United States
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San Francisco, California, United States
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Walnut Creek, California, United States
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West Haven, Connecticut, United States
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Newark, Delaware, United States
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Bay Pines, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Savannah, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Hinsdale, Illinois, United States
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Quincy, Illinois, United States
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Rockford, Illinois, United States
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Fort Wayne, Indiana, United States
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Waterloo, Iowa, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Alexandria, Louisiana, United States
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Baton Rouge, Louisiana, United States
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Covington, Louisiana, United States
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Shreveport, Louisiana, United States
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Shreveport, Louisiana, United States
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Scarborough, Maine, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Bethesda, Maryland, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Saginaw, Michigan, United States
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Duluth, Minnesota, United States
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Rochester, Minnesota, United States
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Bridgeton, Missouri, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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Lincoln, Nebraska, United States
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Camden, New Jersey, United States
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Buffalo, New York, United States
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East Syracuse, New York, United States
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Westbury, New York, United States
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Wilson, North Carolina, United States
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Grand Forks, North Dakota, United States
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Cincinnati, Ohio, United States
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Bend, Oregon, United States
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Medford, Oregon, United States
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Salem, Oregon, United States
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Hershey, Pennsylvania, United States
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York, Pennsylvania, United States
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Sioux Falls, South Dakota, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Kingwood, Texas, United States
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Lubbock, Texas, United States
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Round Rock, Texas, United States
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Fairfax, Virginia, United States
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Fredericksburg, Virginia, United States
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Olympia, Washington, United States
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Seattle, Washington, United States
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Silverdale, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Wenatchee, Washington, United States
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Buenos Aires, Argentina
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CABA, Argentina
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La Plata, Argentina
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Pilar, Argentina
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Rosario, Argentina
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Darlinghurst, Australia
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Hyde Park, Australia
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Southport, Australia
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Wollongong, Australia
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Innsbruck, Austria
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Krems, Austria
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Rankweil, Austria
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Vienna, Austria
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Vienna, Austria
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Anderlecht, Belgium
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Brussels, Belgium
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Charleroi, Belgium
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Kortrijk, Belgium
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Ottignies, Belgium
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Sint-Niklaas, Belgium
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Barretos, Brazil
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Florianópolis, Brazil
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Ijuí, Brazil
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Porto Alegre, Brazil
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, China
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Beijing, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changde, China
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Changsha, China
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Chengdu, China
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Chongqing, China
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Dalian, China
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Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hangzhou, China
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Harbin, China
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Hefei, China
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Hefei, China
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Jinan, China
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Kunming, China
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Linyi, China
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Ningbo, China
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Shanghai, China
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Shenyang, China
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Tianjin, China
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Xi'an, China
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Yueyang, China
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Zhengzhou, China
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Avignon, France
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La Rochelle, France
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Lyon, France
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Rennes, France
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Toulon, France
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Bad Berka, Germany
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Berlin, Germany
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Chemnitz, Germany
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Cologne, Germany
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Essen, Germany
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Esslingen am Neckar, Germany
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Frankfurt, Germany
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Frankfurt am Main, Germany
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Gauting, Germany
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Giessen, Germany
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Großhansdorf, Germany
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Halle, Germany
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Hamburg, Germany
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Hanover, Germany
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Hanover, Germany
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Heidelberg, Germany
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Hemer, Germany
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Homburg, Germany
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Kassel, Germany
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Kiel, Germany
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Magdeburg, Germany
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Minden, Germany
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Moers, Germany
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München, Germany
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Regensburg, Germany
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Velbert, Germany
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Würzburg, Germany
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Budapest, Hungary
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Budapest, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Edelény, Hungary
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Gyöngyös, Hungary
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Gyöngyös - Mátraháza, Hungary
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Győr, Hungary
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Pécs, Hungary
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Székesfehérvár, Hungary
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Törökbálint, Hungary
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Calicut, India
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Delhi, India
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Gurgaon, India
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Kolkata, India
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Madurai, India
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Mumbai, India
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Nashik, India
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New Delhi, India
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Puducherry, India
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Surat, India
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Varanasi, India
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Florence, Italy
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Legnano, Italy
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Livorno, Italy
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Padova, Italy
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Peschiera del Garda, Italy
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Roma, Italy
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Amagasaki-shi, Japan
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Bunkyō City, Japan
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Chūōku, Japan
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Fukuoka, Japan
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Kobe, Japan
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Kōtoku, Japan
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Kumamoto, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Osaka, Japan
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Sendai, Japan
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Shinjuku-ku, Japan
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Takaoka-shi, Japan
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Yokohama, Japan
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Yokohama, Japan
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George Town, Malaysia
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Johor Bahru, Malaysia
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Kuala Lumpur, Malaysia
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Alkmaar, Netherlands
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Ede, Netherlands
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Groningen, Netherlands
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Leidschendam, Netherlands
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Veldhoven, Netherlands
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Zwolle, Netherlands
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Lima, Peru
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Lima, Peru
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Lima, Peru
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Bialystok, Poland
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Bydgoszcz, Poland
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Bystra, Poland
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San Juan, Puerto Rico
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Seoul, South Korea
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Suwon, South Korea
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Suwon, South Korea
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Barcelona, Spain
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Las Palmas de Gran Canaria, Spain
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Lleida, Spain
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Majadahonda, Spain
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Seville, Spain
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Kaohsiung City, Taiwan
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Kaohsiung City, Taiwan
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New Taipei City, Taiwan
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New Taipei City, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taoyuan, Taiwan
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Bangkok, Thailand
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Chiang Mai, Thailand
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Dusit, Thailand
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Nakhon Ratchasima, Thailand
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Songkhla, Thailand
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Ankara, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Yenimahalle, Turkey (Türkiye)
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Aberdeen, United Kingdom
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Cambridge, United Kingdom
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Edinburgh, United Kingdom
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Greater London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Preston, United Kingdom
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Can Tho, Vietnam
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
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Vinh, Vietnam
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) · TrialPath