search
Back to results

Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

Primary Purpose

Advanced Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Cisplatin
Pemetrexed
Cisplatin
Gemcitabine
Sponsored by
Intergroupe Francophone de Cancerologie Thoracique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, IFCT, Maintenance, Switch

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abbeville - CH
  • Centre Hospitalier du Pays d'Aix
  • Clinique Claude Bernard
  • Annemasse - CH
  • Angers - CHU
  • Annecy - CH
  • Hôpital Privé d'Antony
  • Argenteuil -CH
  • Aubenas - CH
  • CH de la Côte Basque
  • Beauvais - CH
  • CHU Besancon - Pneumologie
  • Hôpital Ambroise Paré - Pneumologie
  • Béziers - CH
  • Caen - Centre François Baclesse
  • Caen - CHU Côte de Nacre
  • Cahors - CH
  • CH de Cannes
  • Castelnau Le Lez - Clinique
  • CH Chambery
  • Charleville-Mézières - CH
  • Centre Hospitalier
  • CH
  • Hôpital Percy-Armées - Pneumologie
  • CHU
  • Colmar - CH
  • Creil - GHPSO
  • CHI Créteil
  • CH de Dax
  • Centre d'Oncologie du Parc
  • Centre Georges François Leclerc
  • Draguignan - CH
  • Grenoble - CHU
  • Saint Omer - CHI
  • CH de Jonzac
  • La Roche Sur Yon - CH
  • Le Mans - Centre Hospitalier
  • CHU (Hôpital Calmette) - Pneumologie
  • Lille - GHPSO
  • Limoges - Hôpital du Cluzeau
  • CH de Longjumeau
  • Centre Léon Bérard
  • CH Saint Joseph Saint Luc
  • Hôpital de la Croix Rousse
  • Hôpital Louis Pradel
  • Lyon - Hôpital Jean Mermoz
  • CH de Macon
  • Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
  • Maubeuge - Polyclinique du Parc
  • Meaux - CH
  • Mont de Marsan - CH
  • Montpellier - Clinique Clémentville
  • Centre Hospitalier
  • Mulhouse - CH
  • Nancy - polyclinique Gentilly
  • CHU Nancy
  • Nevers - CH
  • Nice - CAC
  • Orléans - CH
  • Paris - Saint Louis
  • Hopital Tenon - Pneumologie
  • GH Paris Saint-Joseph
  • HIA Val-de-Grâce
  • Hôpital Bichat - Claude - Bernard
  • Paris - Curie
  • Pau - CH
  • HCL - Lyon Sud (Pneumologie)
  • CHU
  • Pontoise - CH
  • Quimper - CH
  • Reims - CHU
  • Institut Jean Godinot
  • Rennes - CHU
  • Roubaix - CH
  • Saint Priest en Jarez - ICL
  • Saint Quentin - CH
  • Saint-Cloud - Centre René Huguenin
  • Salon de Provence - CH
  • Sens - CH
  • Strasbourg - NHC
  • Thonon les bains - CH
  • Toulon - CHI
  • Toulon - HIA
  • Toulouse - CHU Larrey
  • Tourcoing - CH
  • Tours - CHU
  • Valenciennes - Clinique
  • Versailles - CH
  • CHI de la Haute-Saône - Pneumologie
  • CH de Villefranche - Pneumologie
  • Centre Hospitalier Intercommunal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous maintenance Therapy

Maintenance according to the response of induction

Arm Description

Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed

Induction chemotherapy by cisplatin + gemcitabine followed by : continuous maintenance therapy by gemcitabine if response disease switch maintenance therapy by pemetrexed if stable disease

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Disease free survival
Control and response rate
Safety analysis
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

Full Information

First Posted
June 26, 2012
Last Updated
January 12, 2018
Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Collaborators
Groupe Francais De Pneumo-Cancerologie
search

1. Study Identification

Unique Protocol Identification Number
NCT01631136
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Collaborators
Groupe Francais De Pneumo-Cancerologie

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non Small Cell Lung Cancer
Keywords
Non Small Cell Lung Cancer, IFCT, Maintenance, Switch

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
932 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous maintenance Therapy
Arm Type
Active Comparator
Arm Description
Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed
Arm Title
Maintenance according to the response of induction
Arm Type
Experimental
Arm Description
Induction chemotherapy by cisplatin + gemcitabine followed by : continuous maintenance therapy by gemcitabine if response disease switch maintenance therapy by pemetrexed if stable disease
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75 mg/m²
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
500 mg/m²
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
80 mg/m²
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1250 mg/m²
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
around 20 months
Secondary Outcome Measure Information:
Title
Disease free survival
Time Frame
Around 5 months
Title
Control and response rate
Time Frame
After 4 cycles
Title
Safety analysis
Description
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
Time Frame
Around 5 months
Title
treatment exposure
Time Frame
Around 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice PEROL, MD
Organizational Affiliation
Centre Léon Bérard - Lyon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre-Jean SOUQUET, MD, PhD
Organizational Affiliation
Centre Hospitalier Lyon Sud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbeville - CH
City
Abbeville
ZIP/Postal Code
80142
Country
France
Facility Name
Centre Hospitalier du Pays d'Aix
City
Aix-en-Provence
Country
France
Facility Name
Clinique Claude Bernard
City
Albi
Country
France
Facility Name
Annemasse - CH
City
Ambilly
ZIP/Postal Code
74100
Country
France
Facility Name
Angers - CHU
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Annecy - CH
City
Annecy
ZIP/Postal Code
74374
Country
France
Facility Name
Hôpital Privé d'Antony
City
Antony
Country
France
Facility Name
Argenteuil -CH
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Aubenas - CH
City
Aubenas
Country
France
Facility Name
CH de la Côte Basque
City
Bayonne
Country
France
Facility Name
Beauvais - CH
City
Beauvais
Country
France
Facility Name
CHU Besancon - Pneumologie
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Hôpital Ambroise Paré - Pneumologie
City
Boulogne
Country
France
Facility Name
Béziers - CH
City
Béziers
ZIP/Postal Code
34525
Country
France
Facility Name
Caen - Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Caen - CHU Côte de Nacre
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Cahors - CH
City
Cahors
ZIP/Postal Code
46000
Country
France
Facility Name
CH de Cannes
City
Cannes
Country
France
Facility Name
Castelnau Le Lez - Clinique
City
Castelnau
ZIP/Postal Code
34170
Country
France
Facility Name
CH Chambery
City
Chambery
Country
France
Facility Name
Charleville-Mézières - CH
City
Charleville-Mézières
ZIP/Postal Code
08011
Country
France
Facility Name
Centre Hospitalier
City
Chauny
Country
France
Facility Name
CH
City
Cholet
Country
France
Facility Name
Hôpital Percy-Armées - Pneumologie
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
CHU
City
Clermont-Ferrand
Country
France
Facility Name
Colmar - CH
City
Colmar
ZIP/Postal Code
68000
Country
France
Facility Name
Creil - GHPSO
City
Creil
ZIP/Postal Code
60100
Country
France
Facility Name
CHI Créteil
City
Créteil
Country
France
Facility Name
CH de Dax
City
Dax
Country
France
Facility Name
Centre d'Oncologie du Parc
City
Dijon
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
Country
France
Facility Name
Draguignan - CH
City
Draguignan
ZIP/Postal Code
83300
Country
France
Facility Name
Grenoble - CHU
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Saint Omer - CHI
City
Helfaut
ZIP/Postal Code
62570
Country
France
Facility Name
CH de Jonzac
City
Jonzac
Country
France
Facility Name
La Roche Sur Yon - CH
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Le Mans - Centre Hospitalier
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
CHU (Hôpital Calmette) - Pneumologie
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Lille - GHPSO
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Limoges - Hôpital du Cluzeau
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CH de Longjumeau
City
Longjumeau
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
CH Saint Joseph Saint Luc
City
Lyon
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon
Country
France
Facility Name
Hôpital Louis Pradel
City
Lyon
Country
France
Facility Name
Lyon - Hôpital Jean Mermoz
City
Lyon
Country
France
Facility Name
CH de Macon
City
Macon
Country
France
Facility Name
Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
City
Marseille
Country
France
Facility Name
Maubeuge - Polyclinique du Parc
City
Maubeuge
ZIP/Postal Code
59600
Country
France
Facility Name
Meaux - CH
City
Meaux
ZIP/Postal Code
77100
Country
France
Facility Name
Mont de Marsan - CH
City
Mont de Marsan
ZIP/Postal Code
40000
Country
France
Facility Name
Montpellier - Clinique Clémentville
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Centre Hospitalier
City
Montélimar
Country
France
Facility Name
Mulhouse - CH
City
Mulhouse
ZIP/Postal Code
68000
Country
France
Facility Name
Nancy - polyclinique Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
CHU Nancy
City
Nancy
Country
France
Facility Name
Nevers - CH
City
Nevers
ZIP/Postal Code
58033
Country
France
Facility Name
Nice - CAC
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Orléans - CH
City
Orléans
ZIP/Postal Code
45000
Country
France
Facility Name
Paris - Saint Louis
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
Hopital Tenon - Pneumologie
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
GH Paris Saint-Joseph
City
Paris
Country
France
Facility Name
HIA Val-de-Grâce
City
Paris
Country
France
Facility Name
Hôpital Bichat - Claude - Bernard
City
Paris
Country
France
Facility Name
Paris - Curie
City
Paris
Country
France
Facility Name
Pau - CH
City
Pau
ZIP/Postal Code
64046
Country
France
Facility Name
HCL - Lyon Sud (Pneumologie)
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU
City
Poitiers
Country
France
Facility Name
Pontoise - CH
City
Pontoise
Country
France
Facility Name
Quimper - CH
City
Quimper
ZIP/Postal Code
29107
Country
France
Facility Name
Reims - CHU
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Institut Jean Godinot
City
Reims
Country
France
Facility Name
Rennes - CHU
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Roubaix - CH
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Saint Priest en Jarez - ICL
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Saint Quentin - CH
City
Saint Quentin
ZIP/Postal Code
02100
Country
France
Facility Name
Saint-Cloud - Centre René Huguenin
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Salon de Provence - CH
City
Salon de Provence
Country
France
Facility Name
Sens - CH
City
Sens
Country
France
Facility Name
Strasbourg - NHC
City
Strasbourg
ZIP/Postal Code
63000
Country
France
Facility Name
Thonon les bains - CH
City
Thonon les bains
ZIP/Postal Code
74200
Country
France
Facility Name
Toulon - CHI
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Toulon - HIA
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Toulouse - CHU Larrey
City
Toulouse
Country
France
Facility Name
Tourcoing - CH
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Name
Tours - CHU
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Valenciennes - Clinique
City
Valenciennes
ZIP/Postal Code
59304
Country
France
Facility Name
Versailles - CH
City
Versailles
ZIP/Postal Code
78157
Country
France
Facility Name
CHI de la Haute-Saône - Pneumologie
City
Vesoul
Country
France
Facility Name
CH de Villefranche - Pneumologie
City
Villefranche
Country
France
Facility Name
Centre Hospitalier Intercommunal
City
Villeneuve-Saint-Georges
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35051725
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.
Results Reference
derived
Links:
URL
http://www.ifct.fr
Description
IFCT official website

Learn more about this trial

Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

We'll reach out to this number within 24 hrs