Last updated 8 days ago
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
324 patients around the world
Available in Argentina, Chile, United States, Brazil, Spain
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unacceptable toxicity occurs, consent is withdrawn, or another discontinuation criterion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.
AstraZeneca
9Research sites
324Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
To 130 Years
All Gender
Medical requirements
- 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.
- 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 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.
Sites
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Sanatorio Británico - Rosario
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
CEMER Centro Médico de Enfermedades Respiratorias - Vicente Lopez
Recruiting
Centro Médico Caipo (centro para la atención integral de pacientes oncológicos)
Centro Médico Austral OMI - CABA
Recruiting
Centro de Oncología e Investigación Buenos Aires COIBA
Recruiting
StudySAFFRON
SponsorAstraZeneca
Study typeInterventional
Conditions
Non-small cell lung carcinomaLung cancer
Requirements
To 130 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05261399
