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Adjuvant Chemotherapy in Patients With High Risk Stage I Non-squamous Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01817192
Recruitment Status : Active, not recruiting
First Posted : March 25, 2013
Last Update Posted : March 21, 2014
Sponsor:
Collaborator:
Life Technologies Corporation
Information provided by (Responsible Party):
Encore Clinical

Brief 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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Adjuvant Chemotherapy Other: Radiographic surveillance Other: Pervenio™ Lung RS Assay Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2013
Estimated Primary Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Observation
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.
Other: Radiographic surveillance
Serial radiographic surveillance is a current standard of care for stage I lung cancer

Other: 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
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.
Drug: Adjuvant Chemotherapy
Other: 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 Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Disease-Free Survival [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817192


Locations
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United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, California
University of California, Davis Cancer Center
Sacramento, California, United States, 95817
United States, Colorado
University Park Hematology/Oncology
Englewood, Colorado, United States, 80113
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
China, Sichuan
Huaxi Hospital
Chengdu, Sichuan, China
China
Beijing Cancer Hospital
Beijing, China
Xuanwu Hospital
Beijing, China
Shanghai Pulmonary Hospital
Shanghai, China
Zhong Shan Hospital
Shanghai, China
Sponsors and Collaborators
Encore Clinical
Life Technologies Corporation
Investigators
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Principal Investigator: Thierry Jahan, MD University of California, San Francisco

Publications:
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Responsible Party: Encore Clinical
ClinicalTrials.gov Identifier: NCT01817192     History of Changes
Other Study ID Numbers: EC-120888
First Posted: March 25, 2013    Key Record Dates
Last Update Posted: March 21, 2014
Last Verified: March 2014

Keywords provided by Encore Clinical:
Non-Squamous
Adjuvant Chemotherapy

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms