Informations générales (source: ClinicalTrials.gov)
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). (SAFFRON)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
août 2022
décembre 2026
05 octobre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Isabelle MONNET | 29/03/2024 01:30:14 | Contacter | ||
| CLCC INSTITUT CURIE | 04/09/2024 13:49:39 | Contact (sur clinicalTrials) | |||
| HOPITAL FOCH | Jaafar BENNOUNA | 21/10/2024 07:07:24 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 02321 - Saint-Quentin cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 13915 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Research Site - 33076 - Bordeaux Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Research Site - 35033 - Rennes Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 44800 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Research Site - 49933 - Angers - France | Contact (sur clinicalTrials) | ||||
| Research Site - 67091 - Strasbourg Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75005 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75018 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 76000 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Research Site - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Research Site - 92151 - Suresnes Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 93000 - Bobigny - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94010 - Creteil - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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.