Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
Pemetrexed: Pemetrexed (500 mg/m2) Administrative route : IV infusion
Cisplatin: Cisplatin (75 mg/m2) Administrative route : IV infusion
Carboplatin: Carboplatin (AUC5) Administrative route : IV infusion
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Progression-free survival (PFS) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on osimertinib. — Approximately 36.5 months post first subject randomized Defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
Trial sites (214)
Facility
City
Region
Status
Research Site
Orlando
Florida
Research Site
Honolulu
Hawaii
Research Site
New Brunswick
New Jersey
Research Site
New York
New York
Research Site
Nashville
Tennessee
Research Site
Buenos Aires
Argentina
Research Site
CABA
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
Fremantle
Australia
Research Site
Southport
Australia
Research Site
Waratah NSW
Australia
Research Site
Westmead
Australia
Research Site
Brussels
Belgium
Research Site
Ghent
Belgium
Research Site
Roeselare
Belgium
Research Site
Belo Horizonte
Brazil
Research Site
Cachoeiro de Itapemirim
Brazil
Research Site
Ijuí
Brazil
Research Site
Porto Alegre
Brazil
Research Site
Porto Alegre
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
Toronto
Ontario
Research Site
Toronto
Ontario
Research Site
Montreal
Quebec
Research Site
Montreal
Quebec
Research Site
Santiago
Chile
Research Site
Baoding
China
Research Site
Beijing
China
Research Site
Beijing
China
Research Site
Bengbu
China
+ 174 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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