Strategies for Maintenance Therapies in Advanced Non Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Intergroupe Francophone de Cancerologie Thoracique
Sponsor:
Collaborator:
Groupe Francais De Pneumo-Cancerologie
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT01631136
First received: June 26, 2012
Last updated: October 24, 2013
Last verified: July 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease free survival [ Time Frame: Around 5 months ] [ Designated as safety issue: No ]
  • Control and response rate [ Time Frame: After 4 cycles ] [ Designated as safety issue: No ]
  • Safety analysis [ Time Frame: Around 5 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 932
Study Start Date: July 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631136

Contacts
Contact: Franck MORIN contact@ifct.fr
Contact: Elodie AMOUR contact@ifct.fr

  Show 94 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:
No publications provided

Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT01631136     History of Changes
Other Study ID Numbers: IFCT-GFPC-1101
Study First Received: June 26, 2012
Last Updated: October 24, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Pemetrexed
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing 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

ClinicalTrials.gov processed this record on September 16, 2014