Clinical trial NCT01631136: Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
IFCT
Maintenance
Switch
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
Collaborators: name: Groupe Francais De Pneumo-Cancerologie
First posted: 2012-06-28
Enrollment: 932
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall survival
timeFrame: around 20 months
Secondary outcomes:
measure: Disease free survival
timeFrame: Around 5 months
measure: Control and response rate
timeFrame: After 4 cycles
measure: Safety analysis
timeFrame: Around 5 months
measure: treatment exposure
timeFrame: Around 5 months
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Abbeville - CH
city: Aix-en-Provence
country: France
facility: Centre Hospitalier du Pays d'Aix
city: Albi
country: France
facility: Clinique Claude Bernard
city: Ambilly
country: France
facility: Annemasse - CH
city: Angers
country: France
facility: Angers - CHU
city: Annecy
country: France
facility: Annecy - CH
city: Antony
country: France
facility: Hôpital Privé d'Antony
city: Argenteuil
country: France
facility: Argenteuil -CH
city: Aubenas
country: France
facility: Aubenas - CH
city: Bayonne
country: France
facility: CH de la Côte Basque
city: Beauvais
country: France
facility: Beauvais - CH
city: Besancon
country: France
facility: CHU Besancon - Pneumologie
city: Boulogne
country: France
facility: Hôpital Ambroise Paré - Pneumologie
city: Béziers
country: France
facility: Béziers - CH
city: Caen
country: France
facility: Caen - Centre François Baclesse
city: Caen
country: France
facility: Caen - CHU Côte de Nacre
city: Cahors
country: France
facility: Cahors - CH
city: Cannes
country: France
facility: CH de Cannes
city: Castelnau
country: France
facility: Castelnau Le Lez - Clinique
city: Chambery
country: France
facility: CH Chambery
city: Charleville-Mézières
country: France
facility: Charleville-Mézières - CH
city: Chauny
country: France
facility: Centre Hospitalier
city: Cholet
country: France
facility: CH
city: Clamart
country: France
facility: Hôpital Percy-Armées - Pneumologie
city: Clermont-Ferrand
country: France
facility: CHU
city: Colmar
country: France
facility: Colmar - CH
city: Creil
country: France
facility: Creil - GHPSO
city: Créteil
country: France
facility: CHI Créteil
city: Dax
country: France
facility: CH de Dax
city: Dijon
country: France
facility: Centre d'Oncologie du Parc
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Draguignan
country: France
facility: Draguignan - CH
city: Grenoble
country: France
facility: Grenoble - CHU
city: Helfaut
country: France
facility: Saint Omer - CHI
city: Jonzac
country: France
facility: CH de Jonzac
city: La Roche Sur Yon
country: France
facility: La Roche Sur Yon - CH
city: Le Mans
country: France
facility: Le Mans - Centre Hospitalier
city: Lille
country: France
facility: CHU (Hôpital Calmette) - Pneumologie
city: Lille
country: France
facility: Lille - GHPSO
city: Limoges
country: France
facility: Limoges - Hôpital du Cluzeau
city: Longjumeau
country: France
facility: CH de Longjumeau
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: CH Saint Joseph Saint Luc
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Hôpital Louis Pradel
city: Lyon
country: France
facility: Lyon - Hôpital Jean Mermoz
city: Macon
country: France
facility: CH de Macon
city: Marseille
country: France
facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
city: Maubeuge
country: France
facility: Maubeuge - Polyclinique du Parc
city: Meaux
country: France
facility: Meaux - CH
city: Mont de Marsan
country: France
facility: Mont de Marsan - CH
city: Montpellier
country: France
facility: Montpellier - Clinique Clémentville
city: Montélimar
country: France
facility: Centre Hospitalier
city: Mulhouse
country: France
facility: Mulhouse - CH
city: Nancy
country: France
facility: Nancy - polyclinique Gentilly
city: Nancy
country: France
facility: CHU Nancy
city: Nevers
country: France
facility: Nevers - CH
city: Nice
country: France
facility: Nice - CAC
city: Orléans
country: France
facility: Orléans - CH
city: Paris
country: France
facility: Paris - Saint Louis
city: Paris
country: France
facility: Hopital Tenon - Pneumologie
city: Paris
country: France
facility: GH Paris Saint-Joseph
city: Paris
country: France
facility: HIA Val-de-Grâce
city: Paris
country: France
facility: Hôpital Bichat - Claude - Bernard
city: Paris
country: France
facility: Paris - Curie
city: Pau
country: France
facility: Pau - CH
city: Pierre Bénite
country: France
facility: HCL - Lyon Sud (Pneumologie)
city: Poitiers
country: France
facility: CHU
city: Pontoise
country: France
facility: Pontoise - CH
city: Quimper
country: France
facility: Quimper - CH
city: Reims
country: France
facility: Reims - CHU
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Rennes - CHU
city: Roubaix
country: France
facility: Roubaix - CH
city: Saint Priest en Jarez
country: France
facility: Saint Priest en Jarez - ICL
city: Saint Quentin
country: France
facility: Saint Quentin - CH
city: Saint-Cloud
country: France
facility: Saint-Cloud - Centre René Huguenin
city: Salon de Provence
country: France
facility: Salon de Provence - CH
city: Sens
country: France
facility: Sens - CH
city: Strasbourg
country: France
facility: Strasbourg - NHC
city: Thonon les bains
country: France
facility: Thonon les bains - CH
city: Toulon
country: France
facility: Toulon - CHI
city: Toulon
country: France
facility: Toulon - HIA
city: Toulouse
country: France
facility: Toulouse - CHU Larrey
city: Tourcoing
country: France
facility: Tourcoing - CH
city: Tours
country: France
facility: Tours - CHU
city: Valenciennes
country: France
facility: Valenciennes - Clinique
city: Versailles
country: France
facility: Versailles - CH
city: Vesoul
country: France
facility: CHI de la Haute-Saône - Pneumologie
city: Villefranche
country: France
facility: CH de Villefranche - Pneumologie
city: Villeneuve-Saint-Georges
country: France
facility: Centre Hospitalier Intercommunal
Study officials:
affiliation: Centre Léon Bérard - Lyon
name: Maurice PEROL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Lyon Sud
name: Pierre-Jean SOUQUET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.