Condition: Advanced Non Small Cell Lung Cancer · MET Exon 14 Mutation · Sponsor: Intergroupe Francophone de Cancerologie Thoracique
The hypothesize is that tepotinib is more effective than the investigator's choice of treatment in patients with MET-mutated NSCLC who have progressed after at least one first-line treatment. The main benefit concerns patient access to tepotinib. There is currently no access to a new-generation MET TKI in France for METex14 patients, due to lack of comparative data. There are no phase III RCTs underway anywhere in the world. This study is the only opportunity, perhaps the last, to generate comparative data which, if positive, will enable the drug to be reimbursed. With this in mind, the methodology of this study was discussed with the HAS on several occasions beforehand, to ensure that it met their expectations. With a response rate of around 50% and a median progression-free survival of 11 months in previously-treated subjects based on clinical trials data, tepotinib is a key drug for METex14 NSCLC patients, who are generally elderly and frail, and for whom therapeutic options are limited. The investigators expect to observe a benefit for patients treated with tepotinib compared to the control arm in terms of PFS, quality of life, objective response rate and duration of response. The overall survival benefit may be compromised by allowing patients in the control arm to cross over to tepotinib once they have progressed. However, the investigators have decided to maintain this crossover and consequently use PFS as the primary endpoint, as there is no clinical equipoise regar…
This description comes directly from the study's public registry record.
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| Besançon - CHU | Besançon, France | Recruiting |
| Bordeaux - Institut Bergonie | Bordeaux, France | Recruiting |
| Brest - CHU | Brest, France | Recruiting |
| Caen - CRLCC | Caen, France | Recruiting |
| Centre Hospitalier Intercommunal de Créteil | Créteil, France | Recruiting |
| Dijon - Centre Georges-François Leclerc | Dijon, France | Recruiting |
| Grenoble - CHU | Grenoble, France | Recruiting |
| CHD Vendée | La Roche-sur-Yon, France | Recruiting |
| Le Mans - CHG | Le Mans, France | Recruiting |
| CHRU de Lille | Lille, France | Recruiting |
| Centre Léon Bérard | Lyon, France | Recruiting |
| Institut Paoli Calmette | Marseille, France | Recruiting |
+ 17 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06908993