Baptist Health Paducah

Winston C Chua

Principal Investigator

Lauren Higgins

Baptist Health Louisville

Wangjian Zhong

Principal Investigator

Lauren Higgins

Baptist Health Lexington

Firas B Badin

Principal Investigator

Lauren Higgins

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Razor-Encore - A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients With Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as Intermediate or High Risk by a 14-Gene Prognostic Assay

The optimal treatment for Stage I or Stage IIA non-small cell lung cancer (NSCLC) remains controversial. Radiographic surveillance alone has been recommended for stage I and stage IIA patients after the tumor is removed surgically from the lung, and this standard has been based on the fact that no previous clinical trial has demonstrated a benefit for Stage I or Stage IIA NSCLC patients who receive post-operative chemotherapy. These patients, however, have a substantial risk of death within five years after operation, ranging from approximately 30% to 45%, largely due to metastatic disease that is present immediately after surgery but that is undetectable by conventional methods. Some leading organizations therefore currently recommend post-operative chemotherapy as an alternative standard of care in Stage I or Stage IIA NSCLC patients who are considered to be at particularly high-risk. Up until now, however, there has not been a well-validated means to identify stage I and stage IIA NSCLC patients at high risk of death within five years after operation. A new prognostic tool, a 14-Gene Prognostic Assay, which has been validated and definitively demonstrated in large scale studies to identify intermediate and high-risk stage I or Stage IIA patients with non-squamous NSCLC, is now available to all clinicians through a CLIA-certified laboratory. It is therefore now possible to compare the outcomes of patients randomly assigned to one or the other of these competing standards of care.

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Eligibility Criteria


  • Written informed consent
  • Age ≥ 18 years
  • Adequate tissue sample for the 14-Gene Prognostic Assay
  • Histologically documented completely resected (R0) Stage I or Stage IIA 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


  • Final pathologic diagnosis of purse squamous cell histology, pure small cell or pure neuroendocrine histology, or any combination of only these three histologies.
  • Evidence of greater than stage II A 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