Summary

for people ages 18 years and up (full criteria)
at UC Davis
study started
Thierry Jahan (ucsf)

Description

Summary

The optimal treatment for stage I non-small cell lung cancer (NSCLC) remains controversial. Radiographic surveillance alone has been recommended for stage I 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 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 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 NSCLC patients at high risk of death within five years after operation. A new prognostic tool, the Pervenio™ Lung RS Assay, which has been validated and definitively demonstrated in large scale studies to identify high-risk stage I 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 Non-Squamous Non-Small Cell Lung Cancer Identified as High Risk by the Pervenio™ Lung RS Assay

Keywords

Non-Small Cell Lung Cancer Non-Squamous Adjuvant Chemotherapy Lung Neoplasms Carcinoma, Non-Small-Cell Lung Radiographic surveillance Pervenio™ Lung RS Assay

Eligibility

You can join if…

Open to people ages 18 years and up

  • Written informed consent
  • Age ≥ 18 years
  • Adequate tissue sample for Pervenio™ testing
  • Histologically documented completely resected (R0) Stage I non-squamous NSCLC
  • 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 squamous cell histology
  • Evidence of greater than stage I 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

  • University of California, Davis Cancer Center
    Sacramento California 95817 United States
  • University Park Hematology/Oncology
    Englewood Colorado 80113 United States

Lead Scientist

  • Thierry Jahan (ucsf)
    Professor, Medicine. Authored (or co-authored) 54 research publications

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Encore Clinical
ID
NCT01817192
Study Type
Interventional
Last Updated