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

National Cancer Institute (NCI)

Status: Not yet enrolling

Conditions: Stage IIB Non-small Cell Lung Cancer; Stage IB Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IA Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer

Treatments: Other: laboratory biomarker analysis; Other: medical chart review

Study type: Observational

Funder types: NIH

Identifiers

NCT01595074

LACE-BIO-2#1

CDR0000733532

NCI-2012-01965

Details and patient eligibility

About

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.

Full 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.

OUTLINE:

Archived RNA and DNA samples are analyzed for gene expression, mutations, and variations by reverse transcriptase (RT)-polymerase chain reaction (qPCR), mass spectrometry (MassARRAY), molecular inversion probe assay, and microarray assays. Results are then compared with patients' clinical outcomes.

Enrollment: 950 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

950 participants in 1 patient group

Ancillary-Correlative (laboratory biomarkre analysis)

Description:

Archived RNA and DNA samples are analyzed for gene expression, mutations, and variations by RT-qPCR, MassARRAY, molecular inversion probe assay, and microarray assays. Results are then compared with patients' clinical outcomes.

Treatment:

Other: medical chart review

Other: laboratory biomarker analysis