Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion
Principal Investigator
by David R. Gandara, MD

Description

Summary

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

Keywords

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

Eligibility

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

Locations

  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • Providence St. John's Health Center not yet accepting patients
    Santa Monica California 90401 United States

Lead Scientist at UC Davis

  • David R. Gandara, MD
    Professor, Hematology and Oncology. Authored (or co-authored) 478 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Razor Genomics
Links
Sign up for this study
ID
NCT01817192
Study Type
Interventional
Last Updated