Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer
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
1 other identifier
interventional
932
1 country
91
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2012
Longer than P75 for phase_3
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2012
CompletedFirst Posted
Study publicly available on registry
June 28, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedJanuary 17, 2018
January 1, 2018
4.8 years
June 26, 2012
January 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
around 20 months
Secondary Outcomes (4)
Disease free survival
Around 5 months
Control and response rate
After 4 cycles
Safety analysis
Around 5 months
treatment exposure
Around 5 months
Study Arms (2)
Continuous maintenance Therapy
ACTIVE COMPARATORInduction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed
Maintenance according to the response of induction
EXPERIMENTALInduction chemotherapy by cisplatin + gemcitabine followed by : * continuous maintenance therapy by gemcitabine if response disease * switch maintenance therapy by pemetrexed if stable disease
Interventions
500 mg/m²
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (91)
Abbeville - CH
Abbeville, 80142, France
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
Clinique Claude Bernard
Albi, France
Annemasse - CH
Ambilly, 74100, France
Angers - CHU
Angers, 49000, France
Annecy - CH
Annecy, 74374, France
Hôpital Privé d'Antony
Antony, France
Argenteuil -CH
Argenteuil, 95100, France
Aubenas - CH
Aubenas, France
CH de la Côte Basque
Bayonne, France
Beauvais - CH
Beauvais, France
CHU Besancon - Pneumologie
Besançon, 25000, France
Béziers - CH
Béziers, 34525, France
Hôpital Ambroise Paré - Pneumologie
Boulogne, France
Caen - Centre François Baclesse
Caen, 14000, France
Caen - CHU Côte de Nacre
Caen, 14000, France
Cahors - CH
Cahors, 46000, France
CH de Cannes
Cannes, France
Castelnau Le Lez - Clinique
Castelnau, 34170, France
CH Chambery
Chambéry, France
Charleville-Mézières - CH
Charleville-Mézières, 08011, France
Centre Hospitalier
Chauny, France
CH
Cholet, France
Hôpital Percy-Armées - Pneumologie
Clamart, 92140, France
CHU
Clermont-Ferrand, France
Colmar - CH
Colmar, 68000, France
Creil - GHPSO
Creil, 60100, 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, 83300, France
Grenoble - CHU
Grenoble, 38000, France
Saint Omer - CHI
Helfaut, 62570, France
CH de Jonzac
Jonzac, France
La Roche Sur Yon - CH
La Roche-sur-Yon, 85925, France
Le Mans - Centre Hospitalier
Le Mans, 72000, France
CHU (Hôpital Calmette) - Pneumologie
Lille, 59000, France
Lille - GHPSO
Lille, 59000, France
Limoges - Hôpital du Cluzeau
Limoges, 87042, France
CH de Longjumeau
Longjumeau, France
Centre Léon Bérard
Lyon, 69000, 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, 59600, France
CH de Macon
Mâcon, France
Meaux - CH
Meaux, 77100, France
Mont de Marsan - CH
Mont-de-Marsan, 40000, France
Centre Hospitalier
Montélimar, France
Montpellier - Clinique Clémentville
Montpellier, 34070, France
Mulhouse - CH
Mulhouse, 68000, France
Nancy - polyclinique Gentilly
Nancy, 54100, France
CHU Nancy
Nancy, France
Nevers - CH
Nevers, 58033, France
Nice - CAC
Nice, 06000, France
Orléans - CH
Orléans, 45000, France
Paris - Saint Louis
Paris, 75000, France
Hopital Tenon - Pneumologie
Paris, 75020, 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, 64046, France
HCL - Lyon Sud (Pneumologie)
Pierre-Bénite, 69495, France
CHU
Poitiers, France
Pontoise - CH
Pontoise, France
Quimper - CH
Quimper, 29107, France
Reims - CHU
Reims, 51092, France
Institut Jean Godinot
Reims, France
Rennes - CHU
Rennes, 35033, France
Roubaix - CH
Roubaix, 59100, France
Saint-Cloud - Centre René Huguenin
Saint-Cloud, 92210, France
Saint Priest en Jarez - ICL
Saint-Priest-en-Jarez, 42270, France
Saint Quentin - CH
Saint-Quentin, 02100, France
Salon de Provence - CH
Salon-de-Provence, France
Sens - CH
Sens, France
Strasbourg - NHC
Strasbourg, 63000, France
Thonon les bains - CH
Thonon-les-Bains, 74200, France
Toulon - CHI
Toulon, 83000, France
Toulon - HIA
Toulon, 83000, France
Toulouse - CHU Larrey
Toulouse, France
Tourcoing - CH
Tourcoing, 59208, France
Tours - CHU
Tours, 37000, France
Valenciennes - Clinique
Valenciennes, 59304, France
Versailles - CH
Versailles, 78157, France
CHI de la Haute-Saône - Pneumologie
Vesoul, France
CH de Villefranche - Pneumologie
Villefranche, France
Centre Hospitalier Intercommunal
Villeneuve-Saint-Georges, France
Related Publications (1)
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.
PMID: 35051725DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maurice PEROL, MD
Centre Léon Bérard, Lyon
- PRINCIPAL INVESTIGATOR
Pierre-Jean SOUQUET, MD, PhD
Centre Hospitalier Lyon Sud
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2012
First Posted
June 28, 2012
Study Start
July 1, 2012
Primary Completion
May 2, 2017
Study Completion
November 30, 2017
Last Updated
January 17, 2018
Record last verified: 2018-01