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Advanced Non Small Cell Lung CancerPhase 3NCT01631136

Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

A Phase 3 study testing Cisplatin, Pemetrexed and Gemcitabine in people with Advanced Non Small Cell Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 91 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Non Small Cell Lung Cancer
What is being tested?
Cisplatin, Pemetrexed and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
932 participants
Where
91 sitesFrance
Study dates
Jul 2012to 30 Nov 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

91 sites in 1 country.

91 sites in 1 country

France91 sites

  • Abbeville - CH

    Abbeville, 80142

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence

  • Clinique Claude Bernard

    Albi

  • Annemasse - CH

    Ambilly, 74100

  • Angers - CHU

    Angers, 49000

  • Annecy - CH

    Annecy, 74374

  • Hôpital Privé d'Antony

    Antony

  • Argenteuil -CH

    Argenteuil, 95100

  • Aubenas - CH

    Aubenas

  • CH de la Côte Basque

    Bayonne

  • Beauvais - CH

    Beauvais

  • CHU Besancon - Pneumologie

    Besançon, 25000

  • Béziers - CH

    Béziers, 34525

  • Hôpital Ambroise Paré - Pneumologie

    Boulogne

  • Caen - Centre François Baclesse

    Caen, 14000

  • Caen - CHU Côte de Nacre

    Caen, 14000

  • Cahors - CH

    Cahors, 46000

  • CH de Cannes

    Cannes

  • Castelnau Le Lez - Clinique

    Castelnau, 34170

  • CH Chambery

    Chambéry

  • Charleville-Mézières - CH

    Charleville-Mézières, 08011

  • Centre Hospitalier

    Chauny

  • CH

    Cholet

  • Hôpital Percy-Armées - Pneumologie

    Clamart, 92140

  • CHU

    Clermont-Ferrand

  • Colmar - CH

    Colmar, 68000

  • Creil - GHPSO

    Creil, 60100

  • CHI Créteil

    Créteil

  • CH de Dax

    Dax

  • Centre d'Oncologie du Parc

    Dijon

  • Centre Georges François Leclerc

    Dijon

  • Draguignan - CH

    Draguignan, 83300

  • Grenoble - CHU

    Grenoble, 38000

  • Saint Omer - CHI

    Helfaut, 62570

  • CH de Jonzac

    Jonzac

  • La Roche Sur Yon - CH

    La Roche-sur-Yon, 85925

  • Le Mans - Centre Hospitalier

    Le Mans, 72000

  • CHU (Hôpital Calmette) - Pneumologie

    Lille, 59000

  • Lille - GHPSO

    Lille, 59000

  • Limoges - Hôpital du Cluzeau

    Limoges, 87042

  • CH de Longjumeau

    Longjumeau

  • Centre Léon Bérard

    Lyon, 69000

  • CH Saint Joseph Saint Luc

    Lyon

  • Hôpital de la Croix Rousse

    Lyon

  • Hôpital Louis Pradel

    Lyon

  • Lyon - Hôpital Jean Mermoz

    Lyon

  • CH de Macon

    Mâcon

  • Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

    Marseille

  • Maubeuge - Polyclinique du Parc

    Maubeuge, 59600

  • Meaux - CH

    Meaux, 77100

  • Mont de Marsan - CH

    Mont-de-Marsan, 40000

  • Centre Hospitalier

    Montélimar

  • Montpellier - Clinique Clémentville

    Montpellier, 34070

  • Mulhouse - CH

    Mulhouse, 68000

  • Nancy - polyclinique Gentilly

    Nancy, 54100

  • CHU Nancy

    Nancy

  • Nevers - CH

    Nevers, 58033

  • Nice - CAC

    Nice, 06000

  • Orléans - CH

    Orléans, 45000

  • Paris - Saint Louis

    Paris, 75000

  • Hopital Tenon - Pneumologie

    Paris, 75020

  • GH Paris Saint-Joseph

    Paris

  • HIA Val-de-Grâce

    Paris

  • Hôpital Bichat - Claude - Bernard

    Paris

  • Paris - Curie

    Paris

  • Pau - CH

    Pau, 64046

  • HCL - Lyon Sud (Pneumologie)

    Pierre-Bénite, 69495

  • CHU

    Poitiers

  • Pontoise - CH

    Pontoise

  • Quimper - CH

    Quimper, 29107

  • Reims - CHU

    Reims, 51092

  • Institut Jean Godinot

    Reims

  • Rennes - CHU

    Rennes, 35033

  • Roubaix - CH

    Roubaix, 59100

  • Saint-Cloud - Centre René Huguenin

    Saint-Cloud, 92210

  • Saint Priest en Jarez - ICL

    Saint-Priest-en-Jarez, 42270

  • Saint Quentin - CH

    Saint-Quentin, 02100

  • Salon de Provence - CH

    Salon-de-Provence

  • Sens - CH

    Sens

  • Strasbourg - NHC

    Strasbourg, 63000

  • Thonon les bains - CH

    Thonon-les-Bains, 74200

  • Toulon - CHI

    Toulon, 83000

  • Toulon - HIA

    Toulon, 83000

  • Toulouse - CHU Larrey

    Toulouse

  • Tourcoing - CH

    Tourcoing, 59208

  • Tours - CHU

    Tours, 37000

  • Valenciennes - Clinique

    Valenciennes, 59304

  • Versailles - CH

    Versailles, 78157

  • CHI de la Haute-Saône - Pneumologie

    Vesoul

  • CH de Villefranche - Pneumologie

    Villefranche

  • Centre Hospitalier Intercommunal

    Villeneuve-Saint-Georges

Other trials in France

About this study

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

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:

Read more
  • 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.
Keywords
Non Small Cell Lung Cancer, IFCT, Maintenance, Switch
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01631136
Study groupRoleWhat they receive
Continuous maintenance TherapyActive comparatorInduction chemotherapy by cisplatin + pemetrexed and maintenance therapy by pemetrexed
Receives: Drug: Cisplatin; Drug: Pemetrexed
Maintenance according to the response of inductionExperimentalInduction chemotherapy by cisplatin + gemcitabine followed by : * continuous maintenance therapy by gemcitabine if response disease * switch maintenance therapy by pemetrexed if stable disease
Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: around 20 months

Secondary outcomes (4)

  1. Disease free survival

    Measured: Around 5 months

  2. Control and response rate

    Measured: After 4 cycles

  3. 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

    Measured: Around 5 months

  4. treatment exposure

    Measured: Around 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2012 (estimated)
  2. Study startJul 2012
  3. Primary completion2 May 2017
  4. Study completion30 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
932 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01631136
Sponsor's protocol ID
IFCT-GFPC-1101
Status last verified
Jan 2018
First submitted
26 Jun 2012
Last updated
17 Jan 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35051725

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin, Pemetrexed and Gemcitabine in people with Advanced Non Small Cell Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 91 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: around 20 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01631136, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.

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