Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments adjuvant chemotherapy, radiographic surveillance, pervenio™ lung rs assay
Sponsor Encore Clinical
Collaborator Life Technologies Corporation
Start date May 2013
End date April 2021
Trial size 700 participants
Trial identifier NCT01817192, EC-120888

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Post-operative observation of stage I non-small cell lunger cancer with Radiographic Surveillance is a current standard of care. Patients identified as high-risk by the Pervenio™ Lung RS Assay will be randomized either to this arm or the Adjuvant Chemotherapy Arm.
radiographic surveillance
Serial radiographic surveillance is a current standard of care for stage I lung cancer
pervenio™ lung rs assay
This CLIA-approved assay is a standard tool that is now available to all clinicians to improve the prognostic evaluation of patients after resection of early stage non-squamous NSCLC. It will be performed on tumor specimens for patients who are potentially eligible for this study. Patients identified through the assay as high-risk will be randomized to either adjuvant chemotherapy or observation.
(Active Comparator)
Adjuvant Chemotherapy is a current standard of care for high-risk stage I non-small cell lung cancer. Patients identified as high-risk by the Pervenio™ Lung RS Assay will be randomized either to this arm or the Observation Arm.
adjuvant chemotherapy
pervenio™ lung rs assay
This CLIA-approved assay is a standard tool that is now available to all clinicians to improve the prognostic evaluation of patients after resection of early stage non-squamous NSCLC. It will be performed on tumor specimens for patients who are potentially eligible for this study. Patients identified through the assay as high-risk will be randomized to either adjuvant chemotherapy or observation.

Primary Outcomes

Measure
Overall Survival
time frame: 2 years

Secondary Outcomes

Measure
Disease-Free Survival
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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: 1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 AND 2. Platelet count ≥ 100000 cells/mm3 AND 3. Haemoglobin ≥ 9 g/dL (may be transfused to maintain or exceed this level) - Adequate liver function: 1. Total bilirubin < 1.5 x upper limit of normal (ULN) AND 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN - Adequate renal function, with Serum creatinine ≤ 1.5 x ULN - Completely healed incisions Exclusion Criteria: - 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

Additional Information

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
Principal investigator Thierry Jahan, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Encore Clinical.