Overview

This trial is active, not recruiting.

Condition advanced non small cell lung cancer
Treatments cisplatin, pemetrexed, gemcitabine
Phase phase 3
Sponsor Intergroupe Francophone de Cancerologie Thoracique
Collaborator Groupe Francais De Pneumo-Cancerologie
Start date July 2012
End date December 2017
Trial size 932 participants
Trial identifier NCT01631136, IFCT-GFPC-1101

Summary

In France, lung cancer is responsible for more than 30000 each year. Progress was made in treatment of lung cancer in the last five years due to targeted therapies and to strategical evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of this strategical evolution. It is based on maintaining continuous therapeutical pression in order to preserve the therapeutical benefit obtained by the first line (induction chemotherapy). Several clinical trials showed that maintenance strategies increase the duration of controlled disease.

There is two types of maintenance strategies:

- Continuous maintenance : prolongation of the treatment initially associated with platin until progression

- Switch maintenance : introduction of a new treatment after the end of induction chemotherapy

The aim of this study is to compare two maintenance strategies

- A continuous maintenance by pemetrexed

- A switch maintenance or a continuous maintenance according to the response of induction chemotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed
cisplatin
75 mg/m²
pemetrexed
500 mg/m²
(Experimental)
Induction chemotherapy by cisplatin + gemcitabine followed by : continuous maintenance therapy by gemcitabine if response disease switch maintenance therapy by pemetrexed if stable disease
pemetrexed
500 mg/m²
cisplatin
80 mg/m²
gemcitabine
1250 mg/m²

Primary Outcomes

Measure
Overall survival
time frame: around 20 months

Secondary Outcomes

Measure
Disease free survival
time frame: Around 5 months
Control and response rate
time frame: After 4 cycles
Safety analysis
time frame: Around 5 months
treatment exposure
time frame: Around 5 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title 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
Principal investigator Maurice PEROL, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Intergroupe Francophone de Cancerologie Thoracique.