Trial Information
Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Inclusion Criteria:
- non-squamous stage III non-small cell lung cancer
- measurable disease (RECIST 1.1)
- ECOG performance status 0-1
- normal organ and marrow function
Exclusion Criteria:
- prior chest radiation therapy
- history of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma
in situ of the cervix) within the last five years.
- Prior therapy with known specific inhibitors of the EGFR.
- history of severe allergic reaction to prior therapy with monoclonal antibodies
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease-Control Rate
Outcome Time Frame:
16 weeks after inclusion
Safety Issue:
No
Principal Investigator
Jean Trédaniel, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
IFCT, GH Paris Saint-Joseph
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
IFCT-0803
NCT ID:
NCT01102231
Start Date:
March 2010
Completion Date:
December 2013
Related Keywords:
- Stage III Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms