Spots Global Cancer Trial Database for Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
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Trial Identification
Brief Title: Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
Official Title: A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).
Study ID: NCT05261399
Study Description
Brief Summary: Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib.
Detailed Description: This is a multicentre, Phase III, randomised, open-label study to investigate the efficacy and safety of savolitinib administered orally in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on first- or second-line treatment with osimertinib as the most recent therapy. 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Criteria in Solid Tumours 1.1 (RECIST 1.1) is assessed by the investigator, unacceptable toxicity occurs, consent is withdrawn, or another discontinuation criterion is met.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, La Jolla, California, United States
Research Site, Orange City, Florida, United States
Research Site, Orlando, Florida, United States
Research Site, Honolulu, Hawaii, United States
Research Site, Evergreen Park, Illinois, United States
Research Site, Boston, Massachusetts, United States
Research Site, Boston, Massachusetts, United States
Research Site, Detroit, Michigan, United States
Research Site, Florham Park, New Jersey, United States
Research Site, New Brunswick, New Jersey, United States
Research Site, New York, New York, United States
Research Site, Canton, Ohio, United States
Research Site, Nashville, Tennessee, United States
Research Site, Berazategui, , Argentina
Research Site, Buenos Aires, , Argentina
Research Site, Caba, , Argentina
Research Site, Cordoba, , Argentina
Research Site, Florida, , Argentina
Research Site, La Rioja, , Argentina
Research Site, Rosario, , Argentina
Research Site, Rosario, , Argentina
Research Site, San Miguel de Tucumán, , Argentina
Research Site, Viedma, , Argentina
Research Site, Clayton, , Australia
Research Site, Fremantle, , Australia
Research Site, Geelong, , Australia
Research Site, Liverpool, , Australia
Research Site, Waratah NSW, , Australia
Research Site, Graz, , Austria
Research Site, Salzburg, , Austria
Research Site, Wien, , Austria
Research Site, Bruxelles, , Belgium
Research Site, Bruxelles, , Belgium
Research Site, Edegem, , Belgium
Research Site, Gent, , Belgium
Research Site, Hasselt, , Belgium
Research Site, Mons, , Belgium
Research Site, Roeselare, , Belgium
Research Site, Sint-Niklaas, , Belgium
Research Site, Belo Horizonte, , Brazil
Research Site, Brasilia, , Brazil
Research Site, Cachoeiro de Itapemirim, , Brazil
Research Site, Curitiba, , Brazil
Research Site, Ijuí, , Brazil
Research Site, Ipatinga, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Rio De Janeiro, , Brazil
Research Site, Rio De Janeiro, , Brazil
Research Site, Salvador, , Brazil
Research Site, Salvador, , Brazil
Research Site, São Paulo, , Brazil
Research Site, São Paulo, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Vitória, , Brazil
Research Site, Haskovo, , Bulgaria
Research Site, Pleven, , Bulgaria
Research Site, Plovdiv, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Varna, , Bulgaria
Research Site, Vratsa, , Bulgaria
Research Site, Mississauga, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Temuco, , Chile
Research Site, Baoding, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Bengbu, , China
Research Site, Changchun, , China
Research Site, Changsha, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Chongqing, , China
Research Site, Fuzhou, , China
Research Site, Fuzhou, , China
Research Site, Hangzhou, , China
Research Site, Hankou,Wuhan, , China
Research Site, Harbin, , China
Research Site, Hefei, , China
Research Site, Jinan, , China
Research Site, Linyi, , China
Research Site, Nanchang, , China
Research Site, Qingdao, , China
Research Site, Shanghai, , China
Research Site, Shenyang, , China
Research Site, Shenzhen, , China
Research Site, Wuhan, , China
Research Site, Xiangfan, , China
Research Site, Xian, , China
Research Site, Yichang, , China
Research Site, Zhengzhou, , China
Research Site, Angers, , France
Research Site, Bobigny, , France
Research Site, Bordeaux Cedex, , France
Research Site, Brest, , France
Research Site, Creteil, , France
Research Site, Dijon, , France
Research Site, Marseille, , France
Research Site, Montpellier, , France
Research Site, Paris, , France
Research Site, Paris, , France
Research Site, Poitiers, , France
Research Site, Rennes Cedex 9, , France
Research Site, Rouen, , France
Research Site, Saint-Herblain, , France
Research Site, Saint-Quentin cedex, , France
Research Site, Strasbourg Cedex, , France
Research Site, Suresnes Cedex, , France
Research Site, Berlin, , Germany
Research Site, Berlin, , Germany
Research Site, Chemnitz, , Germany
Research Site, Frankfurt A. Main, , Germany
Research Site, Gauting, , Germany
Research Site, Homburg, , Germany
Research Site, Immenhausen, , Germany
Research Site, Löwenstein, , Germany
Research Site, Muenster, , Germany
Research Site, München, , Germany
Research Site, Stuttgart, , Germany
Research Site, Wangen, , Germany
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Chaidari, , Greece
Research Site, Heraklion, , Greece
Research Site, Larissa, , Greece
Research Site, Rio, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Thessaloniki, , Greece
Research Site, HKG, , Hong Kong
Research Site, Hong Kong, , Hong Kong
Research Site, Kowloon, , Hong Kong
Research Site, Afula, , Israel
Research Site, Ashdod, , Israel
Research Site, Be'er Ya'akov, , Israel
Research Site, Hadera, , Israel
Research Site, Jerusalem, , Israel
Research Site, Tel Aviv, , Israel
Research Site, Avellino, , Italy
Research Site, Aviano, , Italy
Research Site, Catania, , Italy
Research Site, Meldola, , Italy
Research Site, Milano, , Italy
Research Site, Milan, , Italy
Research Site, Modena, , Italy
Research Site, Monserrato, , Italy
Research Site, Napoli, , Italy
Research Site, Orbassano, , Italy
Research Site, Padova, , Italy
Research Site, Parma, , Italy
Research Site, Perugia, , Italy
Research Site, Peschiera Del Garda, , Italy
Research Site, Roma, , Italy
Research Site, Roma, , Italy
Research Site, Treviso, , Italy
Research Site, Bunkyo-ku, , Japan
Research Site, Chuo-ku, , Japan
Research Site, Fukuoka-shi, , Japan
Research Site, Hirosaki-shi, , Japan
Research Site, Hiroshima-shi, , Japan
Research Site, Iwakuni-shi, , Japan
Research Site, Kanazawa-shi, , Japan
Research Site, Kashiwa, , Japan
Research Site, Kobe-shi, , Japan
Research Site, Kobe, , Japan
Research Site, Kumamoto-shi, , Japan
Research Site, Kurume-shi, , Japan
Research Site, Matsuyama, , Japan
Research Site, Nagasaki-shi, , Japan
Research Site, Okayama-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Osakasayama-shi, , Japan
Research Site, Sakai-shi, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Sendai-shi, , Japan
Research Site, Sunto-gun, , Japan
Research Site, Utsunomiya-shi, , Japan
Research Site, Wakayama-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Goyang-si, , Korea, Republic of
Research Site, Gyeonggi-do, , Korea, Republic of
Research Site, Incheon, , Korea, Republic of
Research Site, Jinju-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Suwon, , Korea, Republic of
Research Site, Ulsan, , Korea, Republic of
Research Site, Kota Bharu, , Malaysia
Research Site, Pulau Pinang, , Malaysia
Research Site, Sabah, , Malaysia
Research Site, Amsterdam, , Netherlands
Research Site, Bacolod, , Philippines
Research Site, Baguio City, , Philippines
Research Site, Cebu City, , Philippines
Research Site, Cebu, , Philippines
Research Site, Davao City, , Philippines
Research Site, Manila, , Philippines
Research Site, Quezon City, , Philippines
Research Site, Quezon City, , Philippines
Research Site, San Juan, , Philippines
Research Site, Bialystok, , Poland
Research Site, Krakow, , Poland
Research Site, Olsztyn, , Poland
Research Site, Łódź, , Poland
Research Site, Chelyabinsk, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Tomsk, , Russian Federation
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Badajoz, , Spain
Research Site, Badalona, , Spain
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Cordoba, , Spain
Research Site, Girona, , Spain
Research Site, La Coruña, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Majadahonda, , Spain
Research Site, Málaga, , Spain
Research Site, Pontevedra, , Spain
Research Site, Sabadell, , Spain
Research Site, Sevilla, , Spain
Research Site, Valencia, , Spain
Research Site, Zaragoza, , Spain
Research Site, Baden, , Switzerland
Research Site, Basel, , Switzerland
Research Site, Bern, , Switzerland
Research Site, Winterthur, , Switzerland
Research Site, Zürich, , Switzerland
Research Site, Chiayi, , Taiwan
Research Site, Hsinchu, , Taiwan
Research Site, Kaohsiung City, , Taiwan
Research Site, Liuying, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Taipei 112, , Taiwan
Research Site, Taipei City, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Bangkok, , Thailand
Research Site, Chiang Mai, , Thailand
Research Site, Dusit, , Thailand
Research Site, Hat Yai, , Thailand
Research Site, Muang, , Thailand
Research Site, Mueang Chanthaburi, , Thailand
Research Site, Adana, , Turkey
Research Site, Ankara, , Turkey
Research Site, Edirne, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Izmir, , Turkey
Research Site, Bristol, , United Kingdom
Research Site, Leicester, , United Kingdom
Research Site, Liverpool, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Newport, , United Kingdom
Research Site, Reading, , United Kingdom
Research Site, Wolverhampton, , United Kingdom
Research Site, Hanoi City, , Vietnam
Research Site, Hanoi, , Vietnam
Research Site, Hanoi, , Vietnam
Research Site, Ho Chi Minh city, , Vietnam
Research Site, Ho Chi Minh, , Vietnam
Contact Details
Name: Shun Lu, Prof,MD,PhD,
Affiliation: Shanghai Chest Hospital, Shanghai JiaoTong University, #241 Huai Hai Road (west), Shanghai, China.
Role: PRINCIPAL_INVESTIGATOR
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