Trial Information

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

OBJECTIVES:

- To evaluate potential prognostic and predictive markers in patients treated with
adjuvant chemotherapy for early-stage non-small cell lung cancer.

- To perform cross-validation analyses for the predictive value of p27, ERCC1, and
beta-tubulin.

- To perform cross-validation analyses for the prognostic value of mucin and BRCA1
expression.

- To perform a pooled analysis for the prognostic impact of p53 protein expression by
IHC, p53 mutation, ras mutation, and EGFR mutation.

OUTLINE: This is a multicenter study. Patients are stratified according to planned
radiotherapy (yes vs no), area of the world (Eastern Europe vs Western Europe vs rest of the
world), and center size (< 20 vs > 20 patients).

Tumor tissue samples are selected from CALGB-9633 and from Lung Adjuvant Cisplatin
Evaluation (LACE) group's studies; ANITA, FRE-IALT, and CAN-NCIC-BR10. Clinical data are
gathered from these patients' protocol records and sent to Institute Gustave-Roussy for
cross-validation studies and pooled analyses.

Tissue samples are analyzed by IHC to identify predictive markers and investigate protein
expression and mutations and by Cox model for prognostic values.