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ACTIVE NOT RECRUITING
NCT05261399
PHASE3

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

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).

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

341

Start Date

2022-08-03

Completion Date

2026-11-23

Last Updated

2026-08-06

Healthy Volunteers

No

Interventions

DRUG

Savolitinib

300 mg savolitinib (3 × 100 mg tablets twice daily) Administrative route : oral

DRUG

Osimertinib

80 mg osimertinib (1 × 80 mg tablet once daily) Administrative route : oral

DRUG

Pemetrexed

Pemetrexed (500 mg/m2) Administrative route : IV infusion

DRUG

Cisplatin

Cisplatin (75 mg/m2) Administrative route : IV infusion

DRUG

Carboplatin

Carboplatin (AUC5) Administrative route : IV infusion

Locations (214)

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Orlando, Florida, United States

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Honolulu, Hawaii, 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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Nashville, Tennessee, United States

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Buenos Aires, Argentina

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CABA, 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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Fremantle, Australia

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Southport, Australia

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Waratah NSW, Australia

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Westmead, Australia

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Brussels, Belgium

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Ghent, Belgium

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Roeselare, Belgium

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Belo Horizonte, Brazil

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Cachoeiro de Itapemirim, Brazil

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Ijuí, Brazil

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Porto Alegre, Brazil

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Porto Alegre, 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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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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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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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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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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Wuhan, China

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Xi'an, China

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Xi'an, China

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Xiangfan, China

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Yichang, China

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Zhengzhou, China

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Bobigny, 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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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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Chemnitz, Germany

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Frankfurt A. Main, Germany

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Gauting, 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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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

And 114 more locations on ClinicalTrials.gov