Summary

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

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

You can join if…

Open to people ages 18 years and up

  • 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. Mixed histologies that include a squamous cell, small cell or neuroendocrine component are eligible for the study, as long as they contain at least some component that is neither squamous cell nor small cell nor neuroendocrine. Eligible resections include segmentectomy, lobectomy, bi-lobectomy, sleeve lobectomy, and pneumonectomy. Resections via wedge resection will not be eligible. Complete resection must also be accompanied by mediastinal lymph node sampling through mediastinoscopy, bronchoscopic sampling (e.g. endobronchial ultrasound guided biopsy) or surgical sampling. Nodes must be sampled from at least one of the following nodal stations: Levels 2, 4, 7, 8, 9 for right- sided cancer and levels 2,4,5,6,7,8 9 for left-sided cancers.
  • Life expectancy excluding NSCLC diagnosis ≥ 5 years
  • ECOG performance status 0-1
  • Adequate haematological function:
  • Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 AND
  • Platelet count ≥ 100000 cells/mm3 AND
  • Haemoglobin ≥ 9 g/dL (may be transfused to maintain or exceed this level)
  • Adequate liver function:
  • Total bilirubin < 1.5 x upper limit of normal (ULN) AND
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN
  • Adequate renal function, with Serum creatinine ≤ 1.5 x ULN
  • Completely healed incisions

You CAN'T join if...

  • 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

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
  • Leonard Cancer Institute accepting new patients
    Mission Viejo California 92961 United States

Lead Scientist at UC Cancer

  • David R. Gandara, MD (ucdavis)
    Professor, Hematology and Oncology. Authored (or co-authored) 473 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Razor Genomics
ID
NCT01817192
Study Type
Interventional
Last Updated