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Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01631136
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Advanced Non Small Cell Lung Cancer Drug: Cisplatin Drug: Pemetrexed Drug: Gemcitabine Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 932 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2012
Primary Completion Date : May 2, 2017
Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Pemetrexed
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: Around 5 months ]
  2. Control and response rate [ Time Frame: After 4 cycles ]
  3. 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

  4. treatment exposure [ Time Frame: Around 5 months ]

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631136


  Show 91 Study Locations
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Groupe Francais De Pneumo-Cancerologie
Investigators
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
ClinicalTrials.gov Identifier: NCT01631136     History of Changes
Other Study ID Numbers: IFCT-GFPC-1101
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Cisplatin
Pemetrexed
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
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