A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients With Completely Resected Stage I Non-Squamous Non-Small Cell Lung Cancer Identified as High Risk by the Pervenio™ Lung RS Assay

Inclusion Criteria:

- Written informed consent

- Age ≥ 18 years

- Adequate tissue sample for Pervenio™ testing

- Histologically documented completely resected (R0) Stage I non-squamous NSCLC

- Life expectancy excluding NSCLC diagnosis ≥ 5 years

- ECOG performance status 0-1

- Adequate haematological function:

1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 AND

2. Platelet count ≥ 100000 cells/mm3 AND

3. Haemoglobin ≥ 9 g/dL (may be transfused to maintain or exceed this level)

- Adequate liver function:

1. Total bilirubin < 1.5 x upper limit of normal (ULN) AND

2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN

- Adequate renal function, with Serum creatinine ≤ 1.5 x ULN

- Completely healed incisions

Exclusion Criteria:

- Final pathologic diagnosis of squamous cell histology

- Evidence of greater than stage I pathologic staging

- Evidence of incomplete resection

- Pregnant or lactating women

- Unwilling to use an effective means of contraception

- Active infection, either systemic or at site of primary resection

- Prior systemic chemotherapy or anti-cancer agent

- Any pre- or post-operative radiotherapy

- Malignancies other than NSCLC within 5 years prior to randomization, except for
adequately treated CIS of the cervix, basal or squamous cell skin cancer, localized
prostate cancer treated surgically, ductal carcinoma in situ treated surgically

- Treatment with any investigational drug or participation in another clinical trial
within 28 days prior to enrollment

- Known hypersensitivity to any of the study treatment agents

- Evidence of any other disease including infection that contraindicates the use of
systemic cytotoxic chemotherapy or puts the patient at high risk for treatment
related complications