Trial Information
Phase III Study Evaluating Two Strategies of Maintenance, One With Pemetrexed in Continuous Strategy and One According to the Response of Induction Chemotherapy, in Non Squamous Non Small Cell Lung Cancer of Advanced Stage
Inclusion Criteria:
- Non-squamous NSCLC histologically or cytologically confirmed
- Stage IV with a cytologically or histologically confirmation for an unique metastasis
- No EGFR activating mutation or indeterminate EGFR mutational status
- At least one measurable lesion
- Age between 18 and 70
- PS 0 or 1
Exclusion Criteria:
- squamous cell lung cancer, small cell lung cancer , neuroendocrine cell lung cancer
- Knowledge of ALK gene rearrangement
- Symptomatic central nervous system metastases or requiring immediate cerebral
radiotherapy
- Superior venous cave syndrome except if treated by implantation of a prosthesis
- Previous anti-tumoral treatment
- Concomitant radiotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
around 20 months
Safety Issue:
No
Principal Investigator
Maurice PEROL, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Léon Bérard - Lyon
Authority:
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study ID:
IFCT-GFPC-1101
NCT ID:
NCT01631136
Start Date:
July 2012
Completion Date:
July 2016
Related Keywords:
- Advanced Non Small Cell Lung Cancer
- Non Small Cell Lung Cancer
- IFCT
- Maintenance
- Switch
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms