Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

January 12, 2018 updated by: Intergroupe Francophone de Cancerologie Thoracique

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
932

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France, 80142
        • Abbeville - CH
      • Aix-en-Provence, France
        • Centre Hospitalier du Pays d'Aix
      • Albi, France
        • Clinique Claude Bernard
      • Ambilly, France, 74100
        • Annemasse - CH
      • Angers, France, 49000
        • Angers - CHU
      • Annecy, France, 74374
        • Annecy - CH
      • Antony, France
        • Hôpital Privé d'Antony
      • Argenteuil, France, 95100
        • Argenteuil -CH
      • Aubenas, France
        • Aubenas - CH
      • Bayonne, France
        • CH de la Côte Basque
      • Beauvais, France
        • Beauvais - CH
      • Besancon, France, 25000
        • CHU Besancon - Pneumologie
      • Boulogne, France
        • Hôpital Ambroise Paré - Pneumologie
      • Béziers, France, 34525
        • Béziers - CH
      • Caen, France, 14000
        • Caen - Centre François Baclesse
      • Caen, France, 14000
        • Caen - CHU Côte de Nacre
      • Cahors, France, 46000
        • Cahors - CH
      • Cannes, France
        • CH de Cannes
      • Castelnau, France, 34170
        • Castelnau Le Lez - Clinique
      • Chambery, France
        • CH Chambéry
      • Charleville-Mézières, France, 08011
        • Charleville-Mézières - CH
      • Chauny, France
        • Centre Hospitalier
      • Cholet, France
        • CH
      • Clamart, France, 92140
        • Hôpital Percy-Armées - Pneumologie
      • Clermont-Ferrand, France
        • CHU
      • Colmar, France, 68000
        • Colmar - CH
      • Creil, France, 60100
        • Creil - GHPSO
      • Créteil, France
        • CHI Créteil
      • Dax, France
        • CH de Dax
      • Dijon, France
        • Centre Georges Francois Leclerc
      • Dijon, France
        • Centre d'Oncologie du Parc
      • Draguignan, France, 83300
        • Draguignan - CH
      • Grenoble, France, 38000
        • Grenoble - CHU
      • Helfaut, France, 62570
        • Saint Omer - CHI
      • Jonzac, France
        • CH de Jonzac
      • La Roche Sur Yon, France, 85925
        • La Roche Sur Yon - CH
      • Le Mans, France, 72000
        • Le Mans - Centre Hospitalier
      • Lille, France, 59000
        • CHU (Hôpital Calmette) - Pneumologie
      • Lille, France, 59000
        • Lille - GHPSO
      • Limoges, France, 87042
        • Limoges - Hôpital du Cluzeau
      • Longjumeau, France
        • CH de Longjumeau
      • Lyon, France, 69000
        • Centre Leon Berard
      • Lyon, France
        • Lyon - Hôpital Jean Mermoz
      • Lyon, France
        • Hôpital de la Croix Rousse
      • Lyon, France
        • Hôpital Louis Pradel
      • Lyon, France
        • CH Saint Joseph Saint Luc
      • Macon, France
        • CH de Macon
      • Marseille, France
        • Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
      • Maubeuge, France, 59600
        • Maubeuge - Polyclinique du Parc
      • Meaux, France, 77100
        • Meaux - CH
      • Mont de Marsan, France, 40000
        • Mont de Marsan - CH
      • Montpellier, France, 34070
        • Montpellier - Clinique Clémentville
      • Montélimar, France
        • Centre Hospitalier
      • Mulhouse, France, 68000
        • Mulhouse - CH
      • Nancy, France
        • Chu Nancy
      • Nancy, France, 54100
        • Nancy - Polyclinique Gentilly
      • Nevers, France, 58033
        • Nevers - CH
      • Nice, France, 06000
        • Nice - CAC
      • Orléans, France, 45000
        • Orléans - CH
      • Paris, France, 75000
        • Paris - Saint Louis
      • Paris, France, 75020
        • Hopital Tenon - Pneumologie
      • Paris, France
        • HIA Val-de-Grâce
      • Paris, France
        • Hôpital Bichat - Claude - Bernard
      • Paris, France
        • Paris - Curie
      • Paris, France
        • GH Paris Saint-Joseph
      • Pau, France, 64046
        • Pau - CH
      • Pierre Bénite, France, 69495
        • HCL - Lyon Sud (Pneumologie)
      • Poitiers, France
        • CHU
      • Pontoise, France
        • Pontoise - CH
      • Quimper, France, 29107
        • Quimper - CH
      • Reims, France, 51092
        • Reims - CHU
      • Reims, France
        • Institut Jean Godinot
      • Rennes, France, 35033
        • Rennes - CHU
      • Roubaix, France, 59100
        • Roubaix - CH
      • Saint Priest en Jarez, France, 42270
        • Saint Priest en Jarez - ICL
      • Saint Quentin, France, 02100
        • Saint Quentin - CH
      • Saint-Cloud, France, 92210
        • Saint-Cloud - Centre René Huguenin
      • Salon de Provence, France
        • Salon de Provence - CH
      • Sens, France
        • Sens - CH
      • Strasbourg, France, 63000
        • Strasbourg - NHC
      • Thonon les bains, France, 74200
        • Thonon les bains - CH
      • Toulon, France, 83000
        • Toulon - CHI
      • Toulon, France, 83000
        • Toulon - HIA
      • Toulouse, France
        • Toulouse - CHU Larrey
      • Tourcoing, France, 59208
        • Tourcoing - CH
      • Tours, France, 37000
        • Tours - CHU
      • Valenciennes, France, 59304
        • Valenciennes - Clinique
      • Versailles, France, 78157
        • Versailles - CH
      • Vesoul, France
        • CHI de la Haute-Saône - Pneumologie
      • Villefranche, France
        • CH de Villefranche - Pneumologie
      • Villeneuve-Saint-Georges, France
        • Centre Hospitalier Intercommunal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Continuous maintenance Therapy
Induction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed
Drug: Cisplatin
75 mg/m²
Drug: Pemetrexed
500 mg/m²
Drug: Cisplatin
80 mg/m²
EXPERIMENTAL: 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
Drug: Cisplatin
75 mg/m²
Drug: Pemetrexed
500 mg/m²
Drug: Cisplatin
80 mg/m²
Drug: Gemcitabine
1250 mg/m²

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall survival
Time Frame: around 20 months
around 20 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: Around 5 months
Around 5 months
Control and response rate
Time Frame: After 4 cycles
After 4 cycles
Safety analysis
Time Frame: Around 5 months
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
treatment exposure
Time Frame: Around 5 months
Around 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intergroupe Francophone de Cancerologie Thoracique

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Groupe Francais De Pneumo-Cancerologie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maurice PEROL, MD, Centre Léon Bérard - Lyon
  • Principal Investigator: Pierre-Jean SOUQUET, MD, PhD, Centre Hospitalier Lyon Sud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IFCT-GFPC-1101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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