Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer

Pts must have undergone complete resection of a histologically proven Stage 1A (pT1N0) or stage 1B (pT2N0) non-small cell lung cancer (except carcinoid) and be currently free of disease. To be pathologic Stage N0, at lease one mediastinal lymph node must have been sampled at resection. Pts must be 6-36 mos from date of surgical resection. Path material from initial diagnosis must be available for review if recurrence occurs. Pts must not have rec'd or currently be rec'g chemo, RT, or biologic agents for lung cancer. Chest x-ray or CT scan < 8 wks prior to registration must show no sign of new or recurrent lung cancer. Pts w/Stage 1A NSCLC must not have recvd any tx other than surgery (as specified in Section 3.12); Pts w/Stage 1B NSCLC are allowed to have received other primary therapy (adjuvant chemo, RT or biologics) in addition to surgery provided criteria of Section 3.12 & 3.13 are met. Pts must be >= 18 yrs. Pts must have normal hepatic function (bili and SGOT or SGPT <= IULN) within 8 wks prior to registration. Pts must have ECOG PS of 0-1. Pts must not be taking mineral, herbal, phytochemical or vitamin supplements at the time of entry and agree to not begin taking such supplements (see Section 3.17). Pts who have been regularly taking > 50 mcg slelenium are eligible, provided they discontinue its use at least 1 month prior to registration. Pts. who have been regularly taking </= 50 mcg selenium are eligible provided they agree to continue taking the same supplement on the same schedule for the entire duration of study participation. Supplements allowed according to guidelines in Section 3.173. Any supplements containing > 50 mcg of selenium are disallowed. Pt must not have any concurrent cancers or any prior cancer history within the past 5 yrs except localized non-melanoma skin cancer. Pts must have no synchronous lesions or mets even if resectable. Pt must have no history of greater than one lung cancer primary at any time.