for people ages 18 years and up (full criteria)
at UC Davis
study started
estimated completion
Principal Investigator
by David R. Gandara, MD (ucdavis)



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.

Official Title

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


Non-Small Cell Lung Cancer, Non-Squamous, Adjuvant Chemotherapy, IFCT, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Radiographic surveillance, 14-Gene Prognostic Assay


For people ages 18 years and up

Inclusion Criteria:

Written informed consent

Age ≥ 18 years

Able to comply with the protocol, including acceptable candidacy for adjuvant chemotherapy according to local institutional standards and likely compliance with follow-up for anticipated length of study (i.e. 5 years from the initiation of enrollment).

Willing to be randomized to chemotherapy.

Histologically documented completely resected (R0) Stage I or IIA non-squamous NSCLC (per 8th edition, TNM staging system)

Adequate tissue sample for the 14-Gene Prognostic Assay

Life expectancy excluding NSCLC diagnosis ≥ 5 years

ECOG performance status 0-1

Completely healed incisions


  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • Providence Medical Foundation Santa Rosa accepting new patients
    Santa Rosa California 95403 United States

Lead Scientist at UC Cancer

  • David R. Gandara, MD (ucdavis)
    Professor, Hematology and Oncology, School of Medicine. Authored (or co-authored) 494 research publications


accepting new patients
Start Date
Completion Date
Razor Genomics
Study Type
Expecting 1050 study participants
Last Updated