A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Stage IIIb or Stage IV Non-Small Cell Lung Cancer as First Line Therapy

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable,
metastatic, or recurrent non-small cell lung cancer Stage IIIB or IV Measurable disease No
known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet
count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT
no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver
metastases present) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active
congestive heart failure Other: Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception No concurrent serious infection No other
malignancy within past 5 years except nonmelanomatous skin cancer No overt psychosis,
mental disability, or incompetence No life threatening illness

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy:
No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified
Radiotherapy: No prior radiotherapy to greater than 25% of the bone marrow No concurrent
radiotherapy Surgery: No concurrent surgery Other: At least 28 days since prior
investigational drugs No other concurrent investigational drugs during or within 28 days
after final dose of study drug No concurrent drugs that induce or inhibit CYP3A enzyme