Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

January 12, 2018 updated by: Intergroupe Francophone de Cancerologie Thoracique

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

932

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France, 80142
        • Abbeville - CH
      • Aix-en-Provence, France
        • Centre Hospitalier du Pays d'Aix
      • Albi, France
        • Clinique Claude Bernard
      • Ambilly, France, 74100
        • Annemasse - CH
      • Angers, France, 49000
        • Angers - CHU
      • Annecy, France, 74374
        • Annecy - CH
      • Antony, France
        • Hôpital Privé d'Antony
      • Argenteuil, France, 95100
        • Argenteuil -CH
      • Aubenas, France
        • Aubenas - CH
      • Bayonne, France
        • CH de la cote basque
      • Beauvais, France
        • Beauvais - CH
      • Besancon, France, 25000
        • CHU Besancon - Pneumologie
      • Boulogne, France
        • Hôpital Ambroise Paré - Pneumologie
      • Béziers, France, 34525
        • Béziers - CH
      • Caen, France, 14000
        • Caen - Centre François Baclesse
      • Caen, France, 14000
        • Caen - CHU Côte de Nacre
      • Cahors, France, 46000
        • Cahors - CH
      • Cannes, France
        • CH de Cannes
      • Castelnau, France, 34170
        • Castelnau Le Lez - Clinique
      • Chambery, France
        • CH Chambéry
      • Charleville-Mézières, France, 08011
        • Charleville-Mézières - CH
      • Chauny, France
        • Centre hospitalier
      • Cholet, France
        • CH
      • Clamart, France, 92140
        • Hôpital Percy-Armées - Pneumologie
      • Clermont-Ferrand, France
        • CHU
      • Colmar, France, 68000
        • Colmar - CH
      • Creil, France, 60100
        • Creil - GHPSO
      • Créteil, France
        • Chi Creteil
      • Dax, France
        • CH de Dax
      • Dijon, France
        • Centre Georges Francois Leclerc
      • Dijon, France
        • Centre d'Oncologie du Parc
      • Draguignan, France, 83300
        • Draguignan - CH
      • Grenoble, France, 38000
        • Grenoble - CHU
      • Helfaut, France, 62570
        • Saint Omer - CHI
      • Jonzac, France
        • CH de Jonzac
      • La Roche Sur Yon, France, 85925
        • La Roche Sur Yon - CH
      • Le Mans, France, 72000
        • Le Mans - Centre Hospitalier
      • Lille, France, 59000
        • CHU (Hôpital Calmette) - Pneumologie
      • Lille, France, 59000
        • Lille - GHPSO
      • Limoges, France, 87042
        • Limoges - Hôpital du Cluzeau
      • Longjumeau, France
        • CH de Longjumeau
      • Lyon, France, 69000
        • Centre Leon Berard
      • Lyon, France
        • Lyon - Hôpital Jean Mermoz
      • Lyon, France
        • Hôpital de la Croix Rousse
      • Lyon, France
        • Hôpital Louis Pradel
      • Lyon, France
        • CH Saint Joseph Saint Luc
      • Macon, France
        • CH de Macon
      • Marseille, France
        • Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
      • Maubeuge, France, 59600
        • Maubeuge - Polyclinique du Parc
      • Meaux, France, 77100
        • Meaux - CH
      • Mont de Marsan, France, 40000
        • Mont de Marsan - CH
      • Montpellier, France, 34070
        • Montpellier - Clinique Clémentville
      • Montélimar, France
        • Centre hospitalier
      • Mulhouse, France, 68000
        • Mulhouse - CH
      • Nancy, France
        • CHU Nancy
      • Nancy, France, 54100
        • Nancy - Polyclinique Gentilly
      • Nevers, France, 58033
        • Nevers - CH
      • Nice, France, 06000
        • Nice - CAC
      • Orléans, France, 45000
        • Orléans - CH
      • Paris, France, 75000
        • Paris - Saint Louis
      • Paris, France, 75020
        • Hopital Tenon - Pneumologie
      • Paris, France
        • HIA Val-de-Grâce
      • Paris, France
        • Hôpital Bichat - Claude - Bernard
      • Paris, France
        • Paris - Curie
      • Paris, France
        • GH Paris Saint-Joseph
      • Pau, France, 64046
        • Pau - CH
      • Pierre Bénite, France, 69495
        • HCL - Lyon Sud (Pneumologie)
      • Poitiers, France
        • CHU
      • Pontoise, France
        • Pontoise - CH
      • Quimper, France, 29107
        • Quimper - CH
      • Reims, France, 51092
        • Reims - CHU
      • Reims, France
        • Institut Jean Godinot
      • Rennes, France, 35033
        • Rennes - CHU
      • Roubaix, France, 59100
        • Roubaix - CH
      • Saint Priest en Jarez, France, 42270
        • Saint Priest en Jarez - ICL
      • Saint Quentin, France, 02100
        • Saint Quentin - CH
      • Saint-Cloud, France, 92210
        • Saint-Cloud - Centre René Huguenin
      • Salon de Provence, France
        • Salon de Provence - CH
      • Sens, France
        • Sens - CH
      • Strasbourg, France, 63000
        • Strasbourg - NHC
      • Thonon les bains, France, 74200
        • Thonon les bains - CH
      • Toulon, France, 83000
        • Toulon - CHI
      • Toulon, France, 83000
        • Toulon - HIA
      • Toulouse, France
        • Toulouse - CHU Larrey
      • Tourcoing, France, 59208
        • Tourcoing - CH
      • Tours, France, 37000
        • Tours - CHU
      • Valenciennes, France, 59304
        • Valenciennes - Clinique
      • Versailles, France, 78157
        • Versailles - CH
      • Vesoul, France
        • CHI de la Haute-Saône - Pneumologie
      • Villefranche, France
        • CH de Villefranche - Pneumologie
      • Villeneuve-Saint-Georges, France
        • Centre Hospitalier Intercommunal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Continuous maintenance Therapy
Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed
Drug: Cisplatin
75 mg/m²
Drug: Pemetrexed
500 mg/m²
Drug: Cisplatin
80 mg/m²
EXPERIMENTAL: Maintenance according to the response of induction

Induction chemotherapy by cisplatin + gemcitabine followed by :

  • continuous maintenance therapy by gemcitabine if response disease
  • switch maintenance therapy by pemetrexed if stable disease
Drug: Cisplatin
75 mg/m²
Drug: Pemetrexed
500 mg/m²
Drug: Cisplatin
80 mg/m²
Drug: Gemcitabine
1250 mg/m²

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: around 20 months
around 20 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: Around 5 months
Around 5 months
Control and response rate
Time Frame: After 4 cycles
After 4 cycles
Safety analysis
Time Frame: 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
Around 5 months
treatment exposure
Time Frame: Around 5 months
Around 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Collaborators

Groupe Francais De Pneumo-Cancerologie

Investigators

  • Principal Investigator: Maurice PEROL, MD, Centre Léon Bérard - Lyon
  • Principal Investigator: Pierre-Jean SOUQUET, MD, PhD, Centre Hospitalier Lyon Sud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

May 2, 2017

Study Completion (ACTUAL)

November 30, 2017

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (ESTIMATE)

June 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCT-GFPC-1101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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