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Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Groupe Francais De Pneumo-Cancerologie
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique Identifier:
First received: June 26, 2012
Last updated: September 1, 2016
Last verified: September 2016

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.

Condition Intervention Phase
Advanced Non Small Cell Lung Cancer
Drug: Cisplatin
Drug: Pemetrexed
Drug: Gemcitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:
  • Overall survival [ Time Frame: around 20 months ]

Secondary Outcome Measures:
  • Disease free survival [ Time Frame: Around 5 months ]
  • Control and response rate [ Time Frame: 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

  • treatment exposure [ Time Frame: Around 5 months ]

Enrollment: 932
Study Start Date: July 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: Pemetrexed
500 mg/m²
Drug: Cisplatin
80 mg/m²
Drug: Gemcitabine
1250 mg/m²


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01631136

  Show 91 Study Locations
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Groupe Francais De Pneumo-Cancerologie
Principal Investigator: Maurice PEROL, MD Centre Léon Bérard - Lyon
Principal Investigator: Pierre-Jean SOUQUET, MD, PhD Centre Hospitalier Lyon Sud
  More Information

Additional Information:
Responsible Party: Intergroupe Francophone de Cancerologie Thoracique Identifier: NCT01631136     History of Changes
Other Study ID Numbers: IFCT-GFPC-1101
Study First Received: June 26, 2012
Last Updated: September 1, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
Non Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on April 28, 2017