Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
Launched by ASTRAZENECA · Feb 25, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment approach for patients with a type of lung cancer called non-small cell lung cancer (NSCLC) that has specific genetic changes. Researchers want to find out if a combination of two drugs, savolitinib and osimertinib, is more effective and safer than traditional chemotherapy for patients whose cancer has continued to grow even after treatment with osimertinib. The goal is to see if this new combination can help control the disease better.
To be eligible for the trial, participants must be at least 18 years old and have been diagnosed with advanced NSCLC that cannot be treated with surgery. They should have a specific mutation in the cancer cells and must have shown signs that their cancer has progressed after taking osimertinib. Participants will undergo tests to ensure they meet health criteria, and they will need to provide a piece of their tumor for analysis. If someone joins the trial, they will receive either the new drug combination or standard chemotherapy, and their health will be closely monitored throughout the study. This trial is currently recruiting participants, and it aims to provide valuable information for improving treatment options for lung cancer patients in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses.
- • 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:
- • Predominant squamous NSCLC, and small cell lung cancer.
- • 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.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, , Spain
Hong Kong, , Hong Kong
Nashville, Tennessee, United States
Varna, , Bulgaria
Chelyabinsk, , Russian Federation
Detroit, Michigan, United States
Gent, , Belgium
Hasselt, , Belgium
Aviano, , Italy
Madrid, , Spain
Orlando, Florida, United States
Milano, , Italy
Barcelona, , Spain
Zaragoza, , Spain
Manchester, , United Kingdom
Canton, Ohio, United States
Roeselare, , Belgium
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Athens, , Greece
Padova, , Italy
Roma, , Italy
Wolverhampton, , United Kingdom
New York, New York, United States
Avellino, , Italy
Graz, , Austria
Salzburg, , Austria
Wien, , Austria
Rennes, , France
Málaga, , Spain
Basel, , Switzerland
Jerusalem, , Israel
Montreal, Quebec, Canada
London, , United Kingdom
Haskovo, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Berlin, , Germany
Stuttgart, , Germany
Hadera, , Israel
Saint Petersburg, , Russian Federation
New Brunswick, New Jersey, United States
Orbassano, , Italy
Kumamoto, , Japan
Boston, Massachusetts, United States
Angers, , France
Girona, , Spain
Leicester, , United Kingdom
Dijon, , France
Tel Aviv, , Israel
La Jolla, California, United States
Quezon City, , Philippines
Tomsk, , Russian Federation
Manila, , Philippines
Quezon City, , Philippines
Singapore, , Singapore
Taipei, , Taiwan
Chiang Mai, , Thailand
Löwenstein, , Germany
Orange City, Florida, United States
Qingdao, , China
Bordeaux Cedex, , France
Sint Niklaas, , Belgium
Geelong, , Australia
Sevilla, , Spain
La Rioja, , Argentina
München, , Germany
Larissa, , Greece
Kowloon, , Hong Kong
Baguio City, , Philippines
Cebu City, , Philippines
Olsztyn, , Poland
Ijuí, , Brazil
Rennes Cedex 9, , France
Bruxelles, , Belgium
Sofia, , Bulgaria
Muenster, , Germany
Rouen, , France
Heraklion, , Greece
Bern, , Switzerland
Majadahonda, , Spain
Valencia, , Spain
Evergreen Park, Illinois, United States
Modena, , Italy
Hiroshima Shi, , Japan
Sapporo Shi, , Japan
Strasbourg Cedex, , France
Milan, , Italy
Chuo Ku, , Japan
Clayton, , Australia
Chongqing, , China
Kuala Lumpur, , Malaysia
Cebu, , Philippines
Wangen, , Germany
Honolulu, Hawaii, United States
Kashiwa, , Japan
Winterthur, , Switzerland
Sunto Gun, , Japan
Poitiers, , France
Bristol, , United Kingdom
Creteil, , France
Chemnitz, , Germany
Bruxelles, , Belgium
Mons, , Belgium
Montpellier, , France
Izmir, , Turkey
Pulau Pinang, , Malaysia
Changchun, , China
Chengdu, , China
Shanghai, , China
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Xi'an, , China
Parma, , Italy
Sakai Shi, , Japan
Krakow, , Poland
Jinju Si, , Korea, Republic Of
Kumamoto Shi, , Japan
Gauting, , Germany
Seoul, , Korea, Republic Of
Changsha, , China
Nanchang, , China
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Kaohsiung City, , Taiwan
Muang, , Thailand
Hanoi, , Vietnam
Ho Chi Minh City, , Vietnam
Rosario, , Argentina
Changsha, , China
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Brest, , France
Catania, , Italy
Okayama Shi, , Japan
Meldola, , Italy
Fuzhou, , China
Shenzhen, , China
Bengbu, , China
Hangzhou, , China
Zhengzhou, , China
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Badalona, , Spain
Bobigny, , France
Iwakuni Shi, , Japan
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Pontevedra, , Spain
Hsinchu, , Taiwan
Hat Yai, , Thailand
Ho Chi Minh, , Vietnam
Edirne, , Turkey
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Ciudad Autonoma De Buenos Aire, , Argentina
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Vratsa, , Bulgaria
Bunkyo Ku, , Japan
Osaka Shi, , Japan
Sendai Shi, , Japan
Wakayama Shi, , Japan
Fremantle, , Australia
Southport, , Australia
Ulsan, , Korea, Republic Of
Westmead, , Australia
Santiago, , Chile
Napoli, , Italy
Suwon, , Korea, Republic Of
Incheon, , Korea, Republic Of
Marseille, , France
Can Tho, , Vietnam
Taichung, , Taiwan
Nagasaki Shi, , Japan
Sabah, , Malaysia
Fukuoka Shi, , Japan
Kanazawa Shi, , Japan
Osakasayama Shi, , Japan
Liverpool, , Australia
Rio De Janeiro, , Brazil
Kobe Shi, , Japan
Immenhausen, , Germany
Hanoi City, , Vietnam
Florida, , Argentina
Porto Alegre, , Brazil
Wuhan, , China
Waratah Nsw, , Australia
Florham Park, New Jersey, United States
Suresnes Cedex, , France
Hirosaki Shi, , Japan
Cordoba, , Spain
Belo Horizonte, , Brazil
Santiago, , Chile
La Coruña, , Spain
Bialystok, , Poland
Davao City, , Philippines
Gyeonggi Do, , Korea, Republic Of
Salvador, , Brazil
Beijing, , China
Hkg, , Hong Kong
Mississauga, Ontario, Canada
Salvador, , Brazil
Linyi, , China
Bangkok, , Thailand
Saint Quentin Cedex, , France
San Miguel De Tucumán, , Argentina
Yichang, , China
Suresnes, , France
Hefei, , China
Edegem, , Belgium
Curitiba, , Brazil
San Juan, , Philippines
São Paulo, , Brazil
Peschiera Del Garda, , Italy
Viedma, , Argentina
Badajoz, , Spain
Istanbul, , Turkey
Caba, , Argentina
Paris, , France
Saint Quentin, , France
Chaidari, , Greece
Be'er Ya'akov, , Israel
Pleven, , Bulgaria
Amsterdam, , Netherlands
Taipei 112, , Taiwan
Ashdod, , Israel
Xian, , China
Temuco, , Chile
Monserrato, , Italy
Brasilia, , Brazil
Montreal, Quebec, Canada
Dusit, , Thailand
Liverpool, , United Kingdom
Newport, , United Kingdom
Reading, , United Kingdom
Saint Herblain, , France
Cordoba, , Argentina
Hankou,Wuhan, , China
Treviso, , Italy
Cachoeiro De Itapemirim, , Brazil
Harbin, , China
Afula, , Israel
Ipatinga, , Brazil
Vitória, , Brazil
Baoding, , China
Jinan, , China
Xiangfan, , China
Frankfurt A. Main, , Germany
Rio, , Greece
Thessaloniki, , Greece
Zürich, , Switzerland
Chiayi, , Taiwan
Liuying, , Taiwan
Taipei City, , Taiwan
Mueang Chanthaburi, , Thailand
Adana, , Turkey
Ankara, , Turkey
Matsuyama, , Japan
Kobe, , Japan
Moscow, , Russian Federation
Petaling Jaya, , Malaysia
Krakow, , Poland
Kota Bahru, , Malaysia
Zürich, , Switzerland
Perugia, , Italy
Buenos Aires, , Argentina
Qingdao, , China
Baden, , Switzerland
Kota Bharu, , Malaysia
Hong Kong, , Hong Kong
Qingdao, , China
Patients applied
Trial Officials
Shun Lu, Prof,MD,PhD,
Principal Investigator
Shanghai Chest Hospital, Shanghai JiaoTong University, #241 Huai Hai Road (west), Shanghai, China.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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