TAilored Post-Surgical Therapy in Early Stage NSCLC

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Standard Chemotherapy
* Drug: Customized Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Standard chemotherapy | Drug: Standard Chemotherapy<br>* Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles<br>|
| Experimental: B<br>Customized treatment | Drug: Customized Treatment<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (% of patients having started the treatment before 2 months after the surgery, with the biological results EGFR and ERCC1) |  | week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival |  | month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Adjuvant