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) - SAFFRO

AstraZeneca AB0 个研究点目标入组 324 人开始时间: 2022年6月1日最近更新: 2024年8月26日

适应症

试验速览

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•- 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 259
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 65

•- 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, 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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