"A Phase II Trial of Gemcitabine, Carboplatin and PS-341 (NSC-681239) in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)."

Pts. must have histologic or cytologically- confirmed NSCLC, Stage IIB w/pleural effusion or IV, advanced or recurrent afater previous surgery and/or radiation; Pts. must have measurable or non-measurable dz and evidence of dz on XR, CT or MRI (effusions, ascites or lab parameters alone are not acceptable); At least 2 weeks must have elapsed from previous surgery and pts. recovered from all associated toxicities; Previous RT must have been completed at least 2 weeks prior to registration and measurable dz inside the RT port is allowed if there is a new lesion; Serum bili </= IULN and SGOT or SGPT </= 2.5 x IULN; Zubrod PS 0-1; Pts. must have no other prior malignancy except; treated basal cell or squamous cell skin ca, in situ cervical, Stage I or II ca in complete remission or disease free from any ca for 5 yrs; Pts. must not be known HIV-positive and receiving anti-retroviral therapy; Pts. must not be planning to receive any other concomitant anticancer treatment incl. chemo, RT, biologic agents or any other investigational drugs; Pts. must not have brain mets; Serum creatinine </= IULN or creatinine clearance >/= 60 cc/min measured or calculated; Pts. must not have had prior systemic chemotherapy or biological agent for NSCLC; ANC >/= 1,500 and PLTS >/= 100,000; Pts. must not have a known hypersensitivity to boron, mannitol or PS-341; </= Grade 1 symptomatic neuropathy-sensory; Pts. must not be pregnant or nursing or of reproductive potential and not agreed to use of effective contraceptive method; Institutions must have IRB approval of S9925 and pts. must be offered participation in S9925.