A Prospective, Randomized, Open-Label, Phase III Trial of Chemotherapy With Carboplatin And Paclitaxel, Versus Carboplatin And Paclitaxel In Combination With ISIS-3521, An Antisense Inhibitor Of Protein Kinase C Alpha In Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer (NSCLC) Stage IV OR Stage IIIB with malignant pleural or pericardial effusion At
least 1 unidimensionally measurable lesion At least 10 mm by spiral CT scan OR At least 20
mm by standard techniques OR Evaluable, non-measurable disease (e.g., ascites, bone
metastases, or malignant pleural or pericardial effusion) No CNS metastases other than
lesions locally treated with surgery or radiosurgery, provided there was no evidence of
CNS progression for at least 4 weeks after completion of treatment No prior or concurrent
brain or other CNS metastases not amenable to local therapy (e.g., multiple brain lesions
or meningeal involvement) Not a candidate for surgical treatment of NSCLC

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 10.0 g/dL No underlying disease associated with
active bleeding Hepatic: Bilirubin no greater than 1.5 mg/dL AST less than 3 times upper
limit of normal (ULN) (5 times ULN in the presence of liver metastases) Renal: Creatinine
no greater than 1.5 mg/dL Other: No active infection requiring therapy No other malignancy
within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior approved or experimental biologic
therapy for NSCLC Chemotherapy: No prior approved or experimental chemotherapy for NSCLC
Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 2
weeks since prior radiotherapy and recovered No prior radiotherapy to indicator lesion(s)
unless an increase in lesion size occurred after completion of radiotherapy Concurrent
localized palliative therapy allowed if pre-approved by sponsor Surgery: See Disease
Characteristics Other: At least 30 days since prior participation in other investigational
study No other concurrent therapy for NSCLC No other concurrent experimental drugs or
anticancer therapy during active treatment of study