Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
NCT ID: NCT05261399
Last Updated: 2025-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
324 participants
INTERVENTIONAL
2022-08-03
2026-12-17
Brief Summary
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Detailed Description
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Approximately 324 participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC will be randomly assigned to study intervention with 1:1 ratio.
Patients will be treated until either objective progression of disease (PD) by Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1) is assessed by the investigator, unacceptable toxicity occurs, consent is withdrawn, or another discontinuation criterion is met.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy
Pemetrexed (500 mg/m2) with either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles (Q3W) for 4 cycles, followed by pemetrexed maintenance (500 mg/m2) Q3W
Pemetrexed
Pemetrexed (500 mg/m2) Administrative route : IV infusion
Cisplatin
Cisplatin (75 mg/m2) or Administrative route : IV infusion
Carboplatin
Carboplatin (AUC5) Administrative route : IV infusion
Savolitinib + Osimertinib
300 mg savolitinib BID plus 80 mg osimertinib QD
Savolitinib
300 mg savolitinib (3 × 100 mg tablets twice daily) Administrative route : oral
Osimertinib
80 mg osimertinib
(1 × 80 mg tablet once daily) Administrative route : oral
Interventions
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Savolitinib
300 mg savolitinib (3 × 100 mg tablets twice daily) Administrative route : oral
Osimertinib
80 mg osimertinib
(1 × 80 mg tablet once daily) Administrative route : oral
Pemetrexed
Pemetrexed (500 mg/m2) Administrative route : IV infusion
Cisplatin
Cisplatin (75 mg/m2) or Administrative route : IV infusion
Carboplatin
Carboplatin (AUC5) Administrative route : IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant must be ≥18 years (≥ 19 years of age in South Korea) at the time of signing the informed consent. All genders are permitted.
* Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy.
* Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M.
* Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy.
* Mandatory provision of FFPE tumour tissue.
* MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment.
* Measurable disease as defined by RECIST 1.1.
* Adequate haematological, liver, renal and cardiac functions, and coagulation parameters.
* ECOG performance status of 0 or 1.
Exclusion Criteria
* Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib.
* Prior or current treatment with savolitinib or another MET inhibitors.
* Spinal cord compression or brain metastases, unless asymptomatic and are stable.
* History or active leptomeningeal carcinomatosis.
* Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 and prior platinum-therapy related Grade 2 neuropathies with the exception of alopecia and haemoglobin ≥ 9.0 g/dL.
* Active/unstable cardiac diseases currently or within the last 6 months, clinically significant ECG abnormalities, and/or factors/medications that may affect QTc intervals.
* History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement.
* Known serious active infection including, but not limited to, tuberculosis, or HIV, HBV or HCV or gastrointestinal disease.
* Receipt of live attenuated vaccine (including against COVID-19) within 30 days prior to the first dose of study intervention.
* Past medical history of ILD, drug-induced ILD, radiation pneumonitis, which required steroid treatment, or any evidence of clinically active ILD.
* Participants currently receiving medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP)3A4 or strong inhibitors of CYP1A2.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Shun Lu, Prof,MD,PhD,
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital, Shanghai JiaoTong University, #241 Huai Hai Road (west), Shanghai, China.
Locations
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Research Site
La Jolla, California, United States
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Orange City, Florida, United States
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Orlando, Florida, United States
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Honolulu, Hawaii, United States
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Evergreen Park, Illinois, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Florham Park, New Jersey, United States
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New Brunswick, New Jersey, United States
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New York, New York, United States
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Canton, Ohio, United States
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Nashville, Tennessee, United States
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Berazategui, , Argentina
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Buenos Aires, , Argentina
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CABA, , Argentina
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Córdoba, , Argentina
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Florida, , Argentina
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La Rioja, , Argentina
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Rosario, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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Viedma, , Argentina
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Clayton, , Australia
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Fremantle, , Australia
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Geelong, , Australia
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Liverpool, , Australia
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Southport, , Australia
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Waratah NSW, , Australia
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Westmead, , Australia
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Graz, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Hasselt, , Belgium
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Mons, , Belgium
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Roeselare, , Belgium
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Sint-Niklaas, , Belgium
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Belo Horizonte, , Brazil
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Brasília, , Brazil
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Cachoeiro de Itapemirim, , Brazil
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Curitiba, , Brazil
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Ijuí, , Brazil
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Ipatinga, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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Salvador, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Vitória, , Brazil
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Haskovo, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Vratsa, , Bulgaria
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Calgary, Alberta, Canada
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Mississauga, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Santiago, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Baoding, , China
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Beijing, , China
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Beijing, , China
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Bengbu, , China
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Changchun, , China
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Changsha, , China
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Changsha, , China
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Fuzhou, , China
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Fuzhou, , China
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Hangzhou, , China
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Hankou,Wuhan, , China
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Harbin, , China
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Hefei, , China
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Jinan, , China
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Linyi, , China
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Nanchang, , China
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Qingdao, , China
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Shanghai, , China
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Shenyang, , China
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Shenzhen, , China
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Wuhan, , China
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Xi'an, , China
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Xi'an, , China
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Xiangyang, , China
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Yichang, , China
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Zhengzhou, , China
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Angers, , France
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Bobigny, , France
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Bordeaux, , France
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Brest, , France
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Créteil, , France
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Dijon, , France
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Marseille, , France
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Montpellier, , France
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Paris, , France
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Paris, , France
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Poitiers, , France
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Rennes, , France
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Rouen, , France
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Saint-Herblain, , France
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Saint-Quentin, , France
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Strasbourg, , France
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Suresnes, , France
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Berlin, , Germany
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Berlin, , Germany
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Chemnitz, , Germany
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Frankfurt A. Main, , Germany
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Gauting, , Germany
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Homburg, , Germany
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Immenhausen, , Germany
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Löwenstein, , Germany
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München, , Germany
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Münster, , Germany
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Stuttgart, , Germany
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Wangen, , Germany
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Athens, , Greece
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Athens, , Greece
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Chaïdári, , Greece
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Heraklion, , Greece
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Larissa, , Greece
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Rio, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Kowloon, , Hong Kong
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Afula, , Israel
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Ashdod, , Israel
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Be’er Ya‘aqov, , Israel
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Hadera, , Israel
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Jerusalem, , Israel
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Tel Aviv, , Israel
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Avellino, , Italy
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Aviano, , Italy
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Catania, , Italy
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Meldola, , Italy
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Milan, , Italy
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Milan, , Italy
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Modena, , Italy
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Monserrato, , Italy
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Napoli, , Italy
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Orbassano, , Italy
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Padua, , Italy
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Parma, , Italy
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Perugia, , Italy
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Peschiera del Garda, , Italy
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Roma, , Italy
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Roma, , Italy
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Treviso, , Italy
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Bunkyō City, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Hirosaki-shi, , Japan
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Hiroshima, , Japan
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Iwakuni-shi, , Japan
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Kanazawa, , Japan
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Kashiwa, , Japan
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Kobe, , Japan
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Kobe, , Japan
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Kumamoto, , Japan
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Kurume-shi, , Japan
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Matsuyama, , Japan
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Nagasaki, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Sakaishi, , Japan
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Sapporo, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Sunto-gun, , Japan
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Utsunomiya, , Japan
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Wakayama, , Japan
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Yokohama, , Japan
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Kota Bharu, , Malaysia
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Kuala Lumpur, , Malaysia
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Petaling Jaya, , Malaysia
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Pulau Pinang, , Malaysia
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Sabak Bernam, , Malaysia
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Amsterdam, , Netherlands
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Bacolod, , Philippines
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Baguio City, , Philippines
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Cebu, , Philippines
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Cebu City, , Philippines
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Davao City, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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San Juan City, , Philippines
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Bialystok, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Olsztyn, , Poland
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Chelyabinsk, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Tomsk, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Goyang-si, , South Korea
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Gyeonggi-do, , South Korea
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Incheon, , South Korea
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Jinju, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Ulsan, , South Korea
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A Coruña, , Spain
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Badajoz, , Spain
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Badalona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Girona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Málaga, , Spain
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Pontevedra, , Spain
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Sabadell, , Spain
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Seville, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Baden, , Switzerland
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Basel, , Switzerland
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Bern, , Switzerland
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Winterthur, , Switzerland
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Zurich, , Switzerland
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Chiayi City, , Taiwan
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Hsinchu, , Taiwan
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Kaohsiung City, , Taiwan
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Liuying, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chanthaburi, , Thailand
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Chiang Mai, , Thailand
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Dusit, , Thailand
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Hat Yai, , Thailand
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Muang, , Thailand
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Bristol, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Newport, , United Kingdom
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Reading, , United Kingdom
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Wolverhampton, , United Kingdom
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Can Tho, , Vietnam
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Related Links
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Lung Cancer Study Locator details (for US)
Other Identifiers
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2024-511169-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-006374-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5087C00001
Identifier Type: -
Identifier Source: org_study_id
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