Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

Phase 3

Completed

• Conditions: Advanced Non Small Cell Lung Cancer
• Interventions: Drug: Cisplatin; Drug: Pemetrexed; Drug: Gemcitabine

• Registration Number: NCT01631136
• Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-28
• Study Start: 2012-07
• Primary Completion: 2017-05-02
• Study Completion: 2017-11-30
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 932

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maintenance according to the response of induction	Gemcitabine	Induction chemotherapy by cisplatin + gemcitabine followed by : * continuous maintenance therapy by gemcitabine if response disease * switch maintenance therapy by pemetrexed if stable disease
Continuous maintenance Therapy	Cisplatin	Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed
Maintenance according to the response of induction	Pemetrexed	Induction chemotherapy by cisplatin + gemcitabine followed by : * continuous maintenance therapy by gemcitabine if response disease * switch maintenance therapy by pemetrexed if stable disease
Continuous maintenance Therapy	Pemetrexed	Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed
Maintenance according to the response of induction	Cisplatin	Induction chemotherapy by cisplatin + gemcitabine followed by : * continuous maintenance therapy by gemcitabine if response disease * switch maintenance therapy by pemetrexed if stable disease

Primary Outcome Measures

Name	Time	Method
Overall survival	around 20 months

Secondary Outcome Measures

Name	Time	Method
Disease free survival	Around 5 months
Control and response rate	After 4 cycles
Safety analysis	Around 5 months	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
treatment exposure	Around 5 months

Trial Locations

Locations (89)

Abbeville - CH; 🇫🇷 Abbeville, France

Centre Hospitalier du Pays d'Aix; 🇫🇷 Aix-en-Provence, France

Clinique Claude Bernard; 🇫🇷 Albi, France

Annemasse - CH; 🇫🇷 Ambilly, France

Angers - CHU; 🇫🇷 Angers, France

Annecy - CH; 🇫🇷 Annecy, France

Hôpital Privé d'Antony; 🇫🇷 Antony, France

Argenteuil -CH; 🇫🇷 Argenteuil, France

Aubenas - CH; 🇫🇷 Aubenas, France

CH de la Côte Basque; 🇫🇷 Bayonne, France

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