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Biomarkers in Predicting Response in Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy

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ClinicalTrials.gov Identifier: NCT01294280
Recruitment Status : Recruiting
First Posted : February 11, 2011
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This research trial studies prognostic and predictive markers in patients with early stage non-small cell lung cancer receiving chemotherapy. Prognostic markers are patient or tumor factors that predict patient survival independent of treatment. Predictive markers are factors that may influence and predict the outcome of treatment in terms of either response or survival benefit. Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer.

Condition or disease Intervention/treatment
Lung Cancer Other: Laboratory Biomarker Analysis

Detailed Description:


I. Evaluate potential prognostic and predictive markers in patients receiving adjuvant chemotherapy for early stage non-small cell lung cancer (NSCLC).

II. To perform cross-validation analyses for the predictive value of cyclin-dependent kinase inhibitor 1B (p27), excision repair cross-complementation group 1 (ERCC1), beta-tubulin and B-cell lymphoma 2 (BCL2)-associated X protein (BAX).

III. To perform cross-validation analyses for the prognostic value of mucin and breast cancer (BRCA)1 expression.

IV. To perform a pooled analysis for the prognostic impact of p53 protein expression by immunohistochemistry (IHC), tumor protein p53 (p53) mutation, ras mutation and epidermal growth factor receptor (EGFR) mutation, and Fas cell surface death receptor (Fas)/Fas ligand (FasL) expression by IHC.

V. Validation of the 15-gene prognostic and predictive messenger ribonucleic acid (mRNA) signature on Lung Adjuvant Cisplatin Evaluation (LACE)-Bio formalin-fixed paraffin-embedded (FFPE) tumor samples.

VI. Exploratory evaluation of the prognostic and predictive values of known potential oncogenic mutations using LACE-Bio FFPE.

VII. Exploratory evaluation of the prognostic and predictive values of gene copy variation using LACE-Bio FFPE tumor samples.

VIII. Exploratory identification and evaluation of prognostic and predictive value of novel genomic aberrations discovered by Next Generation Sequencing on LACE-Bio tumor samples.


Previously collected tissue samples are analyzed by IHC.

Study Design

Study Type : Observational
Estimated Enrollment : 1606 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Participation in the Lung Adjuvant Cisplatin Evaluation Biological Program (LACE-BIO). A Study of Prognostic and Predictive Markers in Early Stage Non-Small Cell Lung Cancer
Study Start Date : July 2008
Estimated Primary Completion Date : January 2100

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Ancillary-Correlative (IHC)
Previously collected tissue samples are analyzed by IHC.
Other: Laboratory Biomarker Analysis
Correlative studies

Outcome Measures

Primary Outcome Measures :
  1. Overall survival [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: Up to 3 years ]

Biospecimen Retention:   Samples With DNA

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients registered to Cancer and Leukemia Group B (CALGB) 9633

Inclusion Criteria:

  • Registration to CALGB9633 for this study
  • Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
  • Informed consent:

    • The subject population to be studied in this protocol includes patients selected from CALGB 9633 for whom an available specimen is present at the Alliance Ohio State University (OSU); all such patients have signed a written informed consent document meeting all federal, state, and institutional guidelines as part of entry into that trial
    • Only cases with adequate tumor formalin FFPE material without depleting the available clinical block(s) are eligible
Contacts and Locations

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): NCT01294280

Contact: Stephen Garziano, MD 315-464-4353

United States, New York
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Stephen Graziano, MD    315-464-4353      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Stephen Graziano, MD State University of New York - Upstate Medical University
More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01294280     History of Changes
Other Study ID Numbers: CALGB-150802
CDR0000600208 ( Registry Identifier: NCI Physician Data Query )
U10CA031946 ( U.S. NIH Grant/Contract )
NCI-2009-00454 ( Registry Identifier: NCI Clinical Trials Reporting Program )
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Alliance for Clinical Trials in Oncology:
Stage I Non-Small Cell Lung Cancer
Stage II Non-Small Cell Lung Cancer

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