Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

NCT ID: NCT01631136

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 932 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2017-11-30

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.

Conditions

Advanced Non Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continuous maintenance Therapy

Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed

Group Type: ACTIVE_COMPARATOR

Cisplatin

Intervention Type: DRUG

75 mg/m²

Pemetrexed

Intervention Type: DRUG

500 mg/m²

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

Group Type: EXPERIMENTAL

Pemetrexed

Intervention Type: DRUG

500 mg/m²

Cisplatin

Intervention Type: DRUG

80 mg/m²

Gemcitabine

Intervention Type: DRUG

1250 mg/m²

Interventions

Cisplatin

75 mg/m²

Intervention Type: DRUG

Pemetrexed

500 mg/m²

Intervention Type: DRUG

Cisplatin

80 mg/m²

Intervention Type: DRUG

Gemcitabine

1250 mg/m²

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Francais De Pneumo-Cancerologie

OTHER

Sponsor Role: collaborator

Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maurice PEROL, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Léon Bérard, Lyon

Pierre-Jean SOUQUET, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Lyon Sud

Locations

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

Beauvais - CH

Beauvais, , France

CHU Besancon - Pneumologie

Besançon, , France

Béziers - CH

Béziers, , France

Hôpital Ambroise Paré - Pneumologie

Boulogne, , France

Caen - Centre François Baclesse

Caen, , France

Caen - CHU Côte de Nacre

Caen, , France

Cahors - CH

Cahors, , France

CH de Cannes

Cannes, , France

Castelnau Le Lez - Clinique

Castelnau, , France

CH Chambery

Chambéry, , France

Charleville-Mézières - CH

Charleville-Mézières, , France

Centre Hospitalier

Chauny, , France

CH

Cholet, , France

Hôpital Percy-Armées - Pneumologie

Clamart, , France

CHU

Clermont-Ferrand, , France

Colmar - CH

Colmar, , France

Creil - GHPSO

Creil, , France

CHI Créteil

Créteil, , France

CH de Dax

Dax, , France

Centre d'Oncologie du Parc

Dijon, , France

Centre Georges François Leclerc

Dijon, , France

Draguignan - CH

Draguignan, , France

Grenoble - CHU

Grenoble, , France

Saint Omer - CHI

Helfaut, , France

CH de Jonzac

Jonzac, , France

La Roche Sur Yon - CH

La Roche-sur-Yon, , France

Le Mans - Centre Hospitalier

Le Mans, , France

CHU (Hôpital Calmette) - Pneumologie

Lille, , France

Lille - GHPSO

Lille, , France

Limoges - Hôpital du Cluzeau

Limoges, , France

CH de Longjumeau

Longjumeau, , France

Centre Léon Bérard

Lyon, , France

CH Saint Joseph Saint Luc

Lyon, , France

Hôpital de la Croix Rousse

Lyon, , France

Hôpital Louis Pradel

Lyon, , France

Lyon - Hôpital Jean Mermoz

Lyon, , France

Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

Marseille, , France

Maubeuge - Polyclinique du Parc

Maubeuge, , France

CH de Macon

Mâcon, , France

Meaux - CH

Meaux, , France

Mont de Marsan - CH

Mont-de-Marsan, , France

Centre Hospitalier

Montélimar, , France

Montpellier - Clinique Clémentville

Montpellier, , France

Mulhouse - CH

Mulhouse, , France

Nancy - polyclinique Gentilly

Nancy, , France

CHU Nancy

Nancy, , France

Nevers - CH

Nevers, , France

Nice - CAC

Nice, , France

Orléans - CH

Orléans, , France

Paris - Saint Louis

Paris, , France

Hopital Tenon - Pneumologie

Paris, , France

GH Paris Saint-Joseph

Paris, , France

HIA Val-de-Grâce

Paris, , France

Hôpital Bichat - Claude - Bernard

Paris, , France

Paris - Curie

Paris, , France

Pau - CH

Pau, , France

HCL - Lyon Sud (Pneumologie)

Pierre-Bénite, , France

CHU

Poitiers, , France

Pontoise - CH

Pontoise, , France

Quimper - CH

Quimper, , France

Reims - CHU

Reims, , France

Institut Jean Godinot

Reims, , France

Rennes - CHU

Rennes, , France

Roubaix - CH

Roubaix, , France

Saint-Cloud - Centre René Huguenin

Saint-Cloud, , France

Saint Priest en Jarez - ICL

Saint-Priest-en-Jarez, , France

Saint Quentin - CH

Saint-Quentin, , France

Salon de Provence - CH

Salon-de-Provence, , France

Sens - CH

Sens, , France

Strasbourg - NHC

Strasbourg, , France

Thonon les bains - CH

Thonon-les-Bains, , France

Toulon - CHI

Toulon, , France

Toulon - HIA

Toulon, , France

Toulouse - CHU Larrey

Toulouse, , France

Tourcoing - CH

Tourcoing, , France

Tours - CHU

Tours, , France

Valenciennes - Clinique

Valenciennes, , France

Versailles - CH

Versailles, , France

CHI de la Haute-Saône - Pneumologie

Vesoul, , France

CH de Villefranche - Pneumologie

Villefranche, , France

Centre Hospitalier Intercommunal

Villeneuve-Saint-Georges, , France

Countries

France

References

Souquet PJ, Audigier-Valette C, Molinier O, Cortot A, Margery J, Moreau L, Gervais R, Barlesi F, Pichon E, Zalcman G, Dumont P, Girard N, Poudenx M, Mazieres J, Cadranel J, Debieuvre D, Dauba J, Langlais A, Morin F, Moro-Sibilot D, Westeel V, Perol M. Tailoring maintenance chemotherapy upon response to induction chemotherapy as compared with pemetrexed continuation maintenance in advanced non-squamous NSCLC patients: Results of the IFCT-GFPC-1101 multicenter randomized phase III trial. Lung Cancer. 2022 Feb;164:84-90. doi: 10.1016/j.lungcan.2021.11.014. Epub 2021 Nov 30.

Reference Type: DERIVED

PMID: 35051725 (View on PubMed)

Related Links

http://www.ifct.fr

IFCT official website

Other Identifiers

IFCT-GFPC-1101

Identifier Type: -

Identifier Source: org_study_id