Phase III Study Comparing Maintenance With Pemetrexed or Gemcitabine to a Surveillance in Elderly Patients (70 Years Old and More) With a Advanced Non Small Cell Lung Cancer Controlled by Induction Chemotherapy.
Phase 3
70 Years
89 Years
70 Years
89 Years
Not Enrolling
Both
Non Small Cell Lung Cancer (Squamous or Non Squamous)
Both
Non Small Cell Lung Cancer (Squamous or Non Squamous)
Trial Information
Phase III Study Comparing Maintenance With Pemetrexed or Gemcitabine to a Surveillance in Elderly Patients (70 Years Old and More) With a Advanced Non Small Cell Lung Cancer Controlled by Induction Chemotherapy.
Inclusion Criteria:
- Histologically or cytologically documented Non Small Cell Lung Cancer non resectable
or non irradiable stage III or stage IV
- EGFR wild type or non feasible EGFR
- 89 >Age ≥ 70
- ECOG Performance status : 0, 1 or 2
- Mini-Mental Test Status (MMS) > 23
Exclusion Criteria:
- Mixed non-small cell and small cell tumors
- Patients with EGFR mutated tumor
- Patient with EML4-ALK translocation
- Evolutive or symptomatic metastasis of central nervous system
- Superior vena cava syndrome
- Calcemia > 2,70 mmol/L
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:
Up to 15 months
Safety Issue:
No
Authority:
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study ID:
IFCT-1201
NCT ID:
NCT01850303
Start Date:
May 2013
Completion Date:
April 2020
Related Keywords:
- Non Small Cell Lung Cancer (Squamous or Non Squamous)
- Elderly
- lung cancer
- switch
- maintenance
- Elderly patients (between 70 and 89 years)
- NSCLC
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|
