Trial Information

Validation of Molecular Prognostic Tests in NSCLC

OBJECTIVES:

Primary

- To develop and validate a clinically useful molecular prognostic signature based on
RNA-expression arrays to accurately distinguish between good and poor outcome in
patients with stage 1B non-small cell lung cancer (NSCLC) (T2aN0M0) by predicting the
risk of cancer recurrence after surgery.

Secondary

- To develop and validate a clinically useful prognostic signature for stage 1A NSCLC
(T1a-bN0M0) that accurately predicts the risk of post-operative cancer recurrence and
is part of a prognostic classifier, which also includes histological, pathological, and
demographic parameters as in the primary objective.

- To determine the effects on test accuracy of the histological subtype (adenocarcinoma
[AC] vs squamous cell [SQA]) for each of the stage-specific prognostic classifiers.

- To determine the relevant statistical features, including accuracy of predicting
overall survival, cancer-specific survival, and disease-free survival at 3 and 5 years,
for each of the prognostic classifiers validated.

- To utilize the validated prognostic signatures and classifiers in stage 1B NSCLC to
determine whether these can reliably predict good outcome among stage II NSCLC
patients.

OUTLINE: This is a multicenter study.

RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression
profiling by Affymetrix Gene Profiling Array (cGMP U133 P2) and reverse
transcriptase-polymerase chain reaction (RT-PCR). Results are then compared and validated
with molecular prognostic signatures that already exist, patients demographics, clinical
characteristics, treatment received, and outcomes. A new prognostic signature is then
constructed and incorporated into combined classifiers.