RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. SGN-15 may be able to locate tumor cells and kill them without harming normal cells. Combining SGN-15 with docetaxel may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of metastatic or recurrent non-small cell lung cancer.

OBJECTIVES:

• Determine the toxicity and safety profile of SGN-15 (cBR96-doxorubicin immunoconjugate) in combination with docetaxel in patients with advanced or recurrent non-small cell lung carcinoma.
• Determine the clinical response rate and response duration in patients treated with this regimen.
• Determine the progression-free survival and overall survival of patients treated with this regimen.

OUTLINE: This is a randomized, open-label study. Patients are stratified according to gender and performance status. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive SGN-15 (cBR96-doxorubicin immunoconjugate) IV over 2 hours followed by docetaxel IV over 30 minutes once weekly on weeks 1-3 and 5-7.
• Arm II: Patients receive docetaxel as in arm I. Quality of life is assessed at baseline and on day 1 of each course.

Patients are followed at 8 weeks.

PROJECTED ACCRUAL: A total of 60 patients (40 in arm I and 20 in arm II) will be accrued for this study within 18-24 months.

• Drug: cBR96-doxorubicin immunoconjugate
• Drug: docetaxel

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic or recurrent (unresectable) non-small cell lung carcinoma

  • Failed at least 1 but no more than 2 prior therapies for metastatic disease OR
  • Disease recurrence within 6 months of completing prior adjuvant chemotherapy
• Lewis-Y antigen expression by immunohistochemistry

• Must have one of the following:

  • Bidimensionally or unidimensionally measurable disease by physical exam or imaging studies
  • Evaluable disease, including bone metastases defined on bone scan OR malignant pleural effusion
• No uncontrolled, symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Hemoglobin at least 10 g/dL
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• No bleeding

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• SGOT no greater than 2.5 times normal
• Alkaline phosphatase no greater than 2.5 times normal (unless documented bony metastasis)
• Amylase/lipase no greater than 1.5 times normal
• No hepatic failure
• No hepatitis B or C

Renal:

• Creatinine no greater than 1.5 times upper limit of normal
• No renal failure

Cardiovascular:

• Left ventricular function at least 50% by echocardiogram or MUGA scan
• No congestive heart failure

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior allergic reactions to recombinant human or murine proteins
• No peripheral neuropathy grade 2 or greater
• No active viral, bacterial, or systemic fungal infections
• No known HIV

• No other primary malignancy except:

  • Non-melanoma skin cancer
  • Carcinoma in situ of the cervix
  • Localized prostate cancer
  • Completely resected stage I or II disease with no evidence of recurrence, from which patient has remained disease-free for more than 3 years
• No uncontrolled significant non-malignant disease
• No uncontrolled peptic ulcer disease
• No serious underlying medical condition that would preclude study participation
• No dementia or altered mental status that would preclude informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 6 months since prior therapeutic or diagnostic murine/human chimeric antibodies or human monoclonal antibodies

  • Must be negative for BR96 antibodies in serum

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or anthracycline)
• No prior docetaxel
• Prior cumulative anthracycline exposure less than 300 mg/m^2

Endocrine therapy:

• At least 4 weeks since prior hormonal therapy
• No concurrent antineoplastic hormonal therapy, except estrogen replacement

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• See Disease Characteristics

Other:

• No other concurrent anti-neoplastic agents
• No other concurrent experimental agents
• No concurrent immunosuppressive medications