Lung Cancer Clinical Trial
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
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.
Full 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Criteria in Solid Tumours 1.1 (RECIST 1.1) is assessed by the investigator, unacceptable toxicity occurs, consent is withdrawn, or another discontinuation criterion is met.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 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 (≥ 20 years of age in Japan) 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:
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 with the exception of alopecia, haemoglobin ≥ 9.0 g/dL, and Grade 2 prior platinum-therapy related neuropathy.
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.
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There are 223 Locations for this study
La Jolla California, 92093, United States
Orange City Florida, 32763, United States
Orlando Florida, 32804, United States
Honolulu Hawaii, 96819, United States
Evergreen Park Illinois, 60805, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
Florham Park New Jersey, 07932, United States
New Brunswick New Jersey, 08903, United States
New York New York, 10032, United States
Canton Ohio, 44718, United States
Nashville Tennessee, 37232, United States
Berazategui , B1884, Argentina
Caba , C1019, Argentina
Ciudad Autonoma De Buenos Aire , C1125, Argentina
Cordoba , X5004, Argentina
Florida , B1602, Argentina
La Rioja , F5300, Argentina
Rosario , 2000, Argentina
Rosario , 2123, Argentina
San Miguel de Tucumán , 4000, Argentina
Viedma , R8500, Argentina
Fremantle , 6160, Australia
Geelong , 3220, Australia
Liverpool , 2170, Australia
Waratah NSW , 2298, Australia
Graz , 8036, Austria
Salzburg , 5020, Austria
Wien , 1140, Austria
Bruxelles , 1200, Belgium
Edegem , B-265, Belgium
Gent , 9000, Belgium
Roeselare , 8800, Belgium
Sint-Niklaas , 9100, Belgium
Belo Horizonte , 30110, Brazil
Brasilia , 70390, Brazil
Cachoeiro de Itapemirim , 29308, Brazil
Curitiba , 80810, Brazil
Ijuà , 98700, Brazil
Ipatinga , 35162, Brazil
Porto Alegre , 90035, Brazil
Porto Alegre , 90050, Brazil
Porto Alegre , 90540, Brazil
Rio De Janeiro , 20231, Brazil
Rio De Janeiro , 22793, Brazil
Salvador , 41253, Brazil
Salvador , 41950, Brazil
São Paulo , 04014, Brazil
São Paulo , 04538, Brazil
São Paulo , 04556, Brazil
Vitória , 29043, Brazil
Haskovo , 6300, Bulgaria
Pleven , 5804, Bulgaria
Plovdiv , 4002, Bulgaria
Sofia , 1407, Bulgaria
Varna , 9010, Bulgaria
Vratsa , 3000, Bulgaria
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H3T 1, Canada
Montreal Quebec, H3T 1, Canada
Santiago , 75007, Chile
Temuco , 48008, Chile
Baoding , 71030, China
Beijing , 10003, China
Beijing , 10114, China
Changchun , 13001, China
Changsha , 41001, China
Changsha , 41003, China
Chengdu , 61004, China
Chongqing , 40001, China
Fuzhou , 35000, China
Fuzhou , 35001, China
Hangzhou , 31002, China
Hankou,Wuhan , 43002, China
Harbin , 15004, China
Hefei , 23003, China
Jinan , 25002, China
Linyi , 27600, China
Nanchang , 33000, China
Qingdao , , China
Shanghai , 20003, China
Shenyang , 11000, China
Wuhan , 43007, China
Xiangfan , 44102, China
Xian , 71010, China
Zhengzhou , 45000, China
Angers , 49933, France
Bobigny , 93000, France
Bordeaux Cedex , 33076, France
Brest , 29200, France
Creteil , 94010, France
Dijon , 21079, France
Marseille , 13915, France
Montpellier , 34298, France
Paris , 75005, France
Paris , 75018, France
Poitiers , 86021, France
Rennes Cedex 9 , 35033, France
Rouen , 76000, France
Saint-Herblain , 44800, France
Saint-Quentin cedex , 02321, France
Strasbourg Cedex , 67091, France
Suresnes , 92150, France
Berlin , 13353, Germany
Berlin , 14165, Germany
Chemnitz , 09113, Germany
Frankfurt A. Main , 60590, Germany
Gauting , 82131, Germany
Homburg , 66424, Germany
Immenhausen , 34376, Germany
Löwenstein , 74245, Germany
Muenster , 48149, Germany
München , 81925, Germany
Stuttgart , 70376, Germany
Wangen , 88239, Germany
Athens , 115 2, Greece
Athens , 11527, Greece
Chaidari , 124 6, Greece
Heraklion , 71110, Greece
Larissa , 41110, Greece
Rio , 265 0, Greece
Thessaloniki , 546 3, Greece
Thessaloniki , 54622, Greece
Afula , 18341, Israel
Ashdod , 77476, Israel
Be'er Ya'akov , 70300, Israel
Hadera , 38100, Israel
Jerusalem , 91031, Israel
Tel Aviv , 64239, Israel
Avellino , 83100, Italy
Aviano , 33081, Italy
Catania , 95123, Italy
Meldola , 47014, Italy
Milano , 20133, Italy
Milan , 20141, Italy
Modena , 41124, Italy
Monserrato , 09042, Italy
Napoli , 80138, Italy
Orbassano , 10043, Italy
Padova , 35128, Italy
Parma , 43126, Italy
Peschiera Del Garda , 37019, Italy
Roma , 00144, Italy
Roma , 00152, Italy
Treviso , 31100, Italy
Bunkyo-ku , 113-8, Japan
Chuo-ku , 104-0, Japan
Hirosaki-shi , 036-8, Japan
Hiroshima-shi , 730-8, Japan
Iwakuni-shi , 740-8, Japan
Kobe-shi , 650-0, Japan
Kumamoto , 860-8, Japan
Kurume-shi , 830-0, Japan
Matsuyama , 791-0, Japan
Nagasaki-shi , 852-8, Japan
Okayama-shi , 700-8, Japan
Osaka-shi , 534-0, Japan
Osakasayama-shi , 589-8, Japan
Sakai-shi , 591-8, Japan
Sapporo-shi , 003-0, Japan
Sapporo-shi , 060-8, Japan
Sendai-shi , 980-0, Japan
Sunto-gun , 411-8, Japan
Utsunomiya-shi , 320-0, Japan
Wakayama-shi , 641-8, Japan
Yokohama-shi , 241-8, Japan
Goyang-si , 10408, Korea, Republic of
Gyeonggi-do , 13620, Korea, Republic of
Jinju-si , 660-7, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Suwon , 16247, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Bialystok , 15-00, Poland
Krakow , 30-51, Poland
Olsztyn , 10-35, Poland
Åódź , 93-33, Poland
Badajoz , 6006, Spain
Badalona , 8916, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Cordoba , 14004, Spain
Girona , 17007, Spain
La Coruña , 15006, Spain
Madrid , 28040, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Majadahonda , 28222, Spain
Málaga , 29010, Spain
Pontevedra , 36312, Spain
Sabadell , 08208, Spain
Sevilla , 41009, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Basel , 4031, Switzerland
Bern , 3010, Switzerland
Winterthur , 8401, Switzerland
Zürich , 8055, Switzerland
Chiayi , 62247, Taiwan
Hsinchu , 300, Taiwan
Liuying , 736, Taiwan
Taichung , 404, Taiwan
Taichung , 40705, Taiwan
Taipei 112 , , Taiwan
Taipei City , 11259, Taiwan
Taipei , 100, Taiwan
Bangkok , 10210, Thailand
Chiang Mai , 50200, Thailand
Dusit , 10300, Thailand
Hat Yai , 90110, Thailand
Muang , 40002, Thailand
Mueang Chanthaburi , 22000, Thailand
Adana , 1370, Turkey
Ankara , 6800, Turkey
Edirne , 22030, Turkey
Istanbul , 34214, Turkey
Istanbul , 34722, Turkey
Izmir , 35100, Turkey
Leicester , LE1 5, United Kingdom
Liverpool , L7 3E, United Kingdom
London , SE1 9, United Kingdom
Manchester , M20 4, United Kingdom
Newport , NP10 , United Kingdom
Reading , RG2 9, United Kingdom
Hanoi City , 10000, Vietnam
Hanoi , 10000, Vietnam
Hanoi , 10000, Vietnam
Ho Chi Minh city , 70000, Vietnam
Ho Chi Minh , 70000, Vietnam
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