This trial is active, not recruiting.

Condition stage iii non-small cell lung cancer
Treatments chemotherapy, erbitux, radiotherapy
Phase phase 2
Target EGFR
Sponsor Intergroupe Francophone de Cancerologie Thoracique
Start date March 2010
End date January 2014
Trial size 106 participants
Trial identifier NCT01102231, IFCT-0803


Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)
The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes
66 Gy (2 Gy by fraction, 5 fractions by week)

Primary Outcomes

Disease-Control Rate
time frame: 16 weeks after inclusion

Secondary Outcomes

Overall Survival
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Principal investigator Jean Trédaniel, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Intergroupe Francophone de Cancerologie Thoracique.