This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatments standard chemotherapy, customized treatment
Phase phase 2/phase 3
Sponsor Intergroupe Francophone de Cancerologie Thoracique
Start date April 2009
End date April 2013
Trial size 152 participants
Trial identifier NCT00775385, Eudract : 2008-004939-38, IFCT-0801


Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. Using this selective approach, patients with stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.

The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous NSCLC.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Standard chemotherapy
standard chemotherapy
Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles
Customized treatment
customized treatment
Mutated EGFR : Erlotinib 150mg/day (1 year) Wild-type EGFR or "undetermined" depends on ERCC1 status : ERCC1 high : no treatment ERCC1 low or undetermined : Pemetrexed Cisplatin, 4 cycles (63 days)

Primary Outcomes

Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1)
time frame: week

Secondary Outcomes

Disease-free Survival
time frame: month

Eligibility Criteria

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

Inclusion Criteria: - NSCLC that is defined as other than predominantly squamous cell histology (squamous cell and/or mixed small cell, non-small cell histology is not permitted) - Surgically resected NSCLC with pathological stage II or stage IIIA non-N2 (TNM classification 2008) - Performance status (PS) = 0 or 1 - 18 years <= age < 70 years - Signed inform consent Exclusion Criteria: - Squamous cell carcinoma - Previous cancer excepted those treated for more than 5 years and considered cured, basocellular skin carcinoma, carcinoma in situ of uterine cervix - Inadequate renal or cardiac functions - Pregnant women - Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade ≥ 2 peripheral neuropathy, peptic ulcer disease, erosive esophagitis or gastritis

Additional Information

Official title Randomized Phase II/III Adjuvant Trial Evaluating Feasibility of Standard (A) vs. Customized Treatment (B) in Stage II or Stage IIIA Non-N2, Non-squamous Non Small Cell Lung Cancer (NSCLC).
Principal investigator Jean-Charles SORIA, Pr
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.