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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Laboratory Biomarker Analysis

Detailed Description

PRIMARY OBJECTIVES:

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.

OUTLINE:

Previously collected tissue samples are analyzed by IHC.

• Study Type: Observational
• Enrollment (Actual): 241

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients registered to Cancer and Leukemia Group B (CALGB) 9633

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival	Up to 3 years

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Stephen Graziano, MD, State University of New York - Upstate Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2008
• Primary Completion (Actual): February 2, 2016
• Study Completion (Actual): February 2, 2016

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 11, 2011

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Stage I Non-Small Cell Lung Cancer; Stage II Non-Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CALGB-150802; U10CA031946 (U.S. NIH Grant/Contract); CDR0000600208 (Registry Identifier: NCI Physician Data Query); NCI-2009-00454 (Registry Identifier: NCI Clinical Trials Reporting Program)