The Identification, Validation and Implemention of Prognostic and/or Predictive Biomarkers for Adjuvant Chemotherapy in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 950
- Locations
- 1
- Primary Endpoint
- Validation of the 15-gene prognostic and predictive mRNA signature by quantitative Nuclease Protection Assay (qNPA) assay and NanoString assay
Study Overview
Brief Summary
This research trial studies biomarkers in predicting treatment response in samples from patients with early-stage non-small cell lung cancer previously treated with adjuvant chemotherapy. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
Detailed Description
OBJECTIVES:
I. Validation of the 15-gene prognostic and predictive messenger (m) ribonucleic acid (RNA) signature on Lung Adjuvant Cisplatin Evaluation (LACE)-Bio formalin-fixed, paraffin-embedded tissue (FFPE) tumor samples.
II. Exploratory evaluation of the prognostic and predictive values of known potential oncogenic mutations using LACE-Bio FFPE tumor samples.
III. Exploratory evaluation of the prognostic and predictive values of gene copy variations using LACE-Bio FFPE tumor samples.
IV. Exploratory identification and evaluation of prognostic and predictive value of novel genomic aberrations discovered by Next Generation Sequencing on LACE-Bio tumor samples.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Samples from patients treated in 4 adjuvant chemotherapy (ACT) for early-stage non-small cell lung cancer (NSCLC) pivotal trials:
- •International Adjuvant Lung Cancer Trail (IALT)
- •Cancer and Leukemia Group B (CALGB)-9633
- •CAN-NCIC-BR10
- •Adjuvant Navelbine International Trialist Association (ANITA)
- •Not specified
- •See Disease Characteristics
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Validation of the 15-gene prognostic and predictive mRNA signature by quantitative Nuclease Protection Assay (qNPA) assay and NanoString assay
Time Frame: Post-RNA extraction from tissue
Prognostic and predictive value of known potential oncogenic mutations and gene copy variations of novel genomic aberrations on disease free survival (DFS) and overall survival (OS)
Time Frame: Post-RNA extraction from tissue
Survival curves will be estimated using Kaplan-Meier methods and compared with the log-rank test. The hypothesis of constant risk ratio over time in the Cox proportional hazards (PH) model will be tested by introducing a time-dependent interaction with the marker or using Schoenfeld's residuals.
Secondary Outcomes
No secondary outcomes reported