Open-label Phase II trial to evaluate safety and efficacy of second-line metronomic oral vinorelbine–atezolizumab combination for stage-IV non-small-cell lung cancer – VinMetAtezo trial, (GFPC 04-2017)

Archive ouverte

Vergnenegre, Alain | Monnet, Isabelle | Bizieux, Acya | Bernardi, Marie | Chiapa, Anne, Marie | Léna, Hervé | Chouaïd, Christos | Robinet, Gilles

Edité par CCSD ; Future Medicine -

International audience. Metronomic chemotherapy is defined as frequent low-dose administration without prolonged drug-free breaks. Combining immune-checkpoint inhibitors and metronomic chemotherapy is a new approach to improve responses and delay onset of resistance to immune-checkpoint inhibitors. This multicenter, Phase II, open-label, single-arm study was designed to assess the safety and efficacy of metronomic oral vinorelbine in combination with immune-checkpoint inhibitors in advanced non-small-cell lung cancers progressing after first-line platinum-based chemotherapy. The recommended metronomic oral vinorelbine dose will be determined during a safety run-in period including 12 patients; the main study will include 59 additional patients. The primary outcome is progression-free survival at 4 months. Secondary outcomes are safety of the combination, median overall survival, objective response rate, disease-control rate at 4 months and quality of life (NCT03801304).

Suggestions

Du même auteur

Cost-utility analysis of maintenance therapy with gemcitabine or erlotinib vs observation with predefined second-line treatment after cisplatin–gemcitabine induction chemotherapy for advanced NSCLC: IFCT-GFPC 0502-Eco phase III study

Archive ouverte | Borget, Isabelle | CCSD

on behalf of the IFCT-GFPC investigators. International audience. Background: The IFCT-GFPC 0502 phase III study reported prolongation of progression-free survival with gemcitabine or erlotinib maintenance vs. obser...

Multicenter phase II trial of nintedanib plus docetaxel in second-line treatment in advanced non-squamous non-small cell lung cancer patients refractory to first-line platin-based chemotherapy (REFRACT GFPC 02–15 study)

Archive ouverte | Auliac, Jean-Bernard | CCSD

International audience. Advanced non-squamous non-small cell lung cancer (NsqNSCLC) progressing at the induction of a first-line of platin-based chemotherapy is a subgroup of patients with poor prognosis and few sec...

Management of patients with synchronous head-and-neck and lung cancers: SYNCHRON GFPC 15-01 study

Archive ouverte | Paleiron, Nicolas | CCSD

International audience. Few data have been published on the management of patients with synchronous head-and-neck cancer (HNC) and lung cancer (LC). This observational study was undertaken to describe the management...

Chargement des enrichissements...