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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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Advanced Non Small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

around 20 months

Safety Issue:

No

Principal Investigator

Maurice PEROL, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Léon Bérard - Lyon

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

IFCT-GFPC-1101

NCT ID:

NCT01631136

Start Date:

July 2012

Completion Date:

July 2016

Related Keywords:

  • Advanced Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer
  • IFCT
  • Maintenance
  • Switch
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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