Phase II Trial of OSI-774 (NSC-718781) in Patients with Advanced Non-Small Cell Lung Cancer and a Performance Status of 2

Pts. must have histological or cytologically-confirmed NSCLC, Stage IIIB w/malignant pelural effusion or IV, new or recurrent after previous surgery and/or radiation; Pts. must have measurable disease, evidence of disease on XR, CT, physical, nuclear exam or MRI; Pts. may have had previous major surgery provided that at least 3 weeks have elapsed and pt. recovered from all toxicities; Measurable residual disease must be present outside the area of surgical resection; Pts. may have received previous RT provided that therapy was completed at least 3 weeks prior to registration and pt. recovered from all toxicities; Measurable disease must be present outside previous port or a new lesion must be present; Serum Bili </= IULN AND EITHER: Alk phos </= IULN and SGOT or SGPT </= 2 x IULN, OR Alk phos </= 4 x IULN and SGOT or SGPT </= IULN, Serum Creatinine </= 2 mg/dl, ANC >/= 1,500 and platelet count >/= 100,000; Zubrod PS 2; Age 18 years or older; Pts. must be willing to provide smoking history; Pts. must have completed the Medical Conditions Questionnaire (Form #61227) per Section 5.14; Pts. must not have prior malignancy EXCEPT: treated baseal cell or squamous cell skin ca, in situ cervical or Stage I or II ca in complete remission, disease-free from any ca for 5 years; Pts. must not have significant h/o cardiac disease, i.e., uncontrolled HTN, unstable angina, CHF, MI w/in 6 months or ventricular arrhythmias requiring medication; Pts. must not have brain metastases; Pts. w/neurologic abnormalities must have negative pretreatment CT or MRI of the brain; Pts must not have GI tract disease resulting in the ability to take enteral meds, malabsorption syndrome, a requirement for IV alimentation, had prior surgical procedures affecting absorption or uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis); Pts. must not be currently receiving or planning to receive concurrent hormonal, biologic or radiation therapy to measurable or non-measurable lesions except patients may receive concurrent palliative RT to small field non-measurable sites (painful bony mets), as long as there are other sites of measurable disease outside the RT port; Pts. must not have received prior hormonal, systemic (chemotherapy), biologic therapy for NSCLC or prior therpay w/EGFR inhibitors; Pts. must not be pregnant or nursing or of reproductive potential and not agreed to use effective contraceptive method; Institutions must have IRB approval of S9925 and pts. must be offered participation in S9925; Register pts. separately to receive institutional credit for specimen submission.