This study is in progress, not accepting new patients

A Study of Chemotherapy in Patients With Intermediate or High Risk Early Stage Lung Cancer

a study on Lung Cancer Non-Small Cell Lung Cancer Lung Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

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, IFCT, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Radiographic surveillance, 14-Gene Prognostic Assay

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Final pathologic diagnosis of pure squamous cell, pure small cell, or pure neuroendocrine histology, or any combination of only these three histologies
  • Evidence of greater than stage IIA 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
  • Systemic chemotherapy or anti-cancer agent within 5 years prior to enrollment
  • Radiotherapy to the chest in the immediate pre- or post- operative period
  • Malignancies other than the current NSCLC within 5 years prior to randomization, except for adequately treated CIS of the cervix, non-melanoma skin cancer, localized prostate cancer treated locally, 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 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
  • Wound dehiscence or infection

Locations

  • UC Davis Comprehensive Cancer Center
    Sacramento California 95817 United States
  • Leonard Cancer Institute
    Mission Viejo California 92961 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Razor Genomics
ID
NCT01817192
Study Type
Interventional
Participants
About 420 people participating
Last Updated