Trial Information

A Randomized Phase III Trial of Adjuvant Chemotherapy in Patients With Early Stage Non-Small Cell Lung Cancer Associated With Banking of Frozen Tumor Specimens and Collection of Gene Expression Profile Data

OBJECTIVES:

Primary

- To determine the potential overall survival benefit of adjuvant chemotherapy in
patients with early stage non-small cell lung cancer (NSCLC) randomized to chemotherapy
compared to those randomized to the present standard of care (observation).

- To collect and process high-quality fresh frozen lung cancer tumor tissue for gene
expression array generation from multiple institutions.

Secondary

- To evaluate selected genomic-based lung cancer prognostic models using data from the
patients randomized to observation after resection.

- To characterize the rate of chemotherapy toxicity for the different chemotherapy
treatment regimens.

- To assess quality of life (QOL) in early stage patients periodically after resection
for NSCLC.

- To examine the impact of chemotherapy on QOL for patients receiving chemotherapy, as
compared to patients in the observation arm.

OUTLINE: This is a multicenter study. Patients are stratified according to pathologic stage
(I vs II) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment
arms within 12 weeks after surgery.

All patients undergo complete resection of disease (i.e., lobectomy, sleeve lobectomy,
bi-lobectomy, or pneumonectomy, but not segmentectomy or wedge resection).

- Arm I: Patients receive 1 of 3 chemotherapy regimens. Treatment repeats every 21 days
for up to 4 courses in the absence of disease progression or unacceptable toxicity.

- Regimen 1: Patients receive vinorelbine ditartrate IV over 10 minutes on days 1
and 8 and cisplatin IV over 60 minutes on day 1.

- Regimen 2: Patients receive docetaxel IV over 60 minutes and cisplatin IV over 60
minutes on day 1.

- Regimen 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1
and 8 and cisplatin IV over 60 minutes on day 1.

- Regimen 4: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin
IV over 60 minutes on day 1.

- Arm II: Patients receive standard care (observation). Tissue obtained at surgery is
examined by RNA microarray analysis. A Lung Metagene Score (LMS) is determined for each
patient and correlated with survival and response.

After completion of study treatment, patients are followed every 6 months for 5 years and
then once a year for 7 years.