Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

Advanced Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631136
• Other study ID #: IFCT-GFPC-1101
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2012
• Last updated: January 12, 2018
• Start date: July 2012
• Est. completion date: November 30, 2017

Study information

• Verified date: January 2018
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 932
• Est. completion date: November 30, 2017
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Non Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• Cisplatin
75 mg/m²
• Pemetrexed
500 mg/m²
• Cisplatin
80 mg/m²
• Gemcitabine
1250 mg/m²

Locations

Country	Name	City	State
France	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	Besancon
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	Chambery
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	CH de Macon	Macon
France	Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques	Marseille
France	Maubeuge - Polyclinique du Parc	Maubeuge
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	CHU Nancy	Nancy
France	Nancy - polyclinique Gentilly	Nancy
France	Nevers - CH	Nevers
France	Nice - CAC	Nice
France	Orléans - CH	Orléans
France	GH Paris Saint-Joseph	Paris
France	HIA Val-de-Grâce	Paris
France	Hôpital Bichat - Claude - Bernard	Paris
France	Hopital Tenon - Pneumologie	Paris
France	Paris - Curie	Paris
France	Paris - Saint Louis	Paris
France	Pau - CH	Pau
France	HCL - Lyon Sud (Pneumologie)	Pierre Bénite
France	CHU	Poitiers
France	Pontoise - CH	Pontoise
France	Quimper - CH	Quimper
France	Institut Jean Godinot	Reims
France	Reims - CHU	Reims
France	Rennes - CHU	Rennes
France	Roubaix - CH	Roubaix
France	Saint Priest en Jarez - ICL	Saint Priest en Jarez
France	Saint Quentin - CH	Saint Quentin
France	Saint-Cloud - Centre René Huguenin	Saint-Cloud
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

Sponsors (2)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique	Groupe Francais De Pneumo-Cancerologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		around 20 months
Secondary	Disease free survival		Around 5 months
Secondary	Control and response rate		After 4 cycles
Secondary	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	Around 5 months
Secondary	treatment exposure		Around 5 months

External Links

•   IFCT official website