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