Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Advanced Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Cisplatin
* Drug: Pemetrexed
* Drug: Cisplatin
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous maintenance Therapy<br>Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed | Drug: Cisplatin<br>* 75 mg/m²<br>Drug: Pemetrexed<br>* 500 mg/m²<br>|
| Experimental: Maintenance according to the response of induction<br>Induction chemotherapy by cisplatin + gemcitabine followed by : continuous maintenance therapy by gemcitabine if response disease switch maintenance therapy by pemetrexed if stable disease | Drug: Pemetrexed<br>* 500 mg/m²<br>Drug: Cisplatin<br>* 80 mg/m²<br>Drug: Gemcitabine<br>* 1250 mg/m²<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | around 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | Around 5 months | 
| Control and response rate |  | After 4 cycles | 
| Safety analysis | Number of patients with at least one adverse event in each arm and number of adverse events with the relationship, intensity and the cycle of appearance | Around 5 months | 
| treatment exposure |  | Around 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non Small Cell Lung Cancer, IFCT, Maintenance, Switch