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| Overall Recruitment Status: Active, currently enrolling |
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| 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) |
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| Region |
Sponsors |
| Hawaii |
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| Acronym |
KP IRB No. |
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13239 |
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| Study Type |
Phase |
| Clinical Trial |
Phase III |
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| Study Population Description |
| Adults, non-small cell lung cancer that has progressed while being treated with osimertinib |
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| Purpose |
| The purpose of the research is to learn more about an investigational drug called savolitinib in combination with osimertinib for the treatment of non-small cell lung cancer (NSCLC). |
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| Detailed Description |
| 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. [ Time Frame: Approximately 55 months post first subject randomized ] |
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| Gender |
Age Limit |
| Male & Female |
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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 (= 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.
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- 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
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- 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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