A Phase II Study Using SGN-15 (cBR96-Doxorubicin Immunoconjugate) in Combination With Docetaxel for the Treatment of Advanced Stage or Recurrent Non-Small Cell Lung Carcinoma

Inclusion Criteria

INCLUSION CRITERIA:

Patients with pathologically confirmed NSCLC which is metastatic or recurrent
(non-resectable), who have failed at least one but no more than two prior therapies for
advanced stage disease or have a recurrence within 6 months of completing adjuvant
chemotherapy.

Lewis-y antigen expression documented by immunohistochemistry for all patients.

Patients must have:

- Bidimensionally or unidimensionally measurable disease on the basis of physical exam
or imaging studies, or

- Evaluable disease: bone metastases defined on bone scan or malignant pleural effusion

Performance status ≤ 2 (ECOG scale) with a life expectancy of at least 3 months

Patients must be at least four weeks from prior treatment (chemotherapy, hormonal therapy,
or definitive radiotherapy)

EXCLUSION CRITERIA:

Prior therapy with TAXOTERE (docetaxel)

Cumulative anthracycline exposure > 300 mg/m2.

More than one primary malignancy with the exception of:

- Non-melanoma skin cancer

- In situ carcinoma of the cervix

- Localized prostate cancer

- Completely resected stage I or II disease with no evidence of recurrent cancer from
which the patient has remained disease free for more than 3 years.

Uncontrolled significant non-malignant disease (e.g. congestive heart failure, bleeding,
renal failure, hepatic failure).

Uncontrolled, symptomatic brain metastasis.

Peripheral neuropathy > grade 2.

Concomitant therapy with other anti-neoplastic agents or experimental agents except for
small volume radiation to a solitary bony metastasis.

Active viral, bacterial or systemic fungal infections including known HIV or Hepatitis B
or C.

Women who are pregnant or breastfeeding

Any serious underlying medical condition, which would impair the ability of the patient to
receive the planned treatment including prior allergic reactions to recombinant human or
murine proteins.

Dementia or altered mental status that would prohibit the understanding and rendering of
informed consent.

Patients with uncontrolled peptic ulcer disease will be excluded.