A Phase II Study Using FDG-PET to Investigate the Dosing Schedule and Response of Combination SGN-15 (cBR96-Doxorubicin Immunoconjugate) and Docetaxel in Patients With Stage IV or Stage IIIB Non-Small Cell Lung Carcinoma Ineligible for Combined Modality Treatment With Curative Intent
SGN-15 is a mAb-drug immunoconjugate comprised of the chimeric anti-Lewis Y (LeY) mAb BR96,
conjugated to doxorubicin. The LeY antigen is found as a glycoprotein at the cell surface
on 90% of carcinomas of the lung. SGN-15 induces its antitumor effect through binding to
the cell surface LeY antigen. It is then rapidly internalized with release of doxorubicin
inside the cell allowing the relative sparing of tissues normally affected by non-specific
The study is open to patients with good performance status (ECOG 0<=2) with stage IIIB or IV
NSCLC which is not potentially curable by surgery or combined modality therapy and who have
received no prior lung cancer chemotherapy for metastatic NSCLC.
Patients will be registered into one of two treatment sequences and wil receive SGN-15 and
docetaxel in 4 week cycles consisting of treatment weekly for 3 weeks, followed by a week of
Arm A will receive a combination os SGN-15 and docetaxel on the same day. Arm B will
receive the combination of SGN-15 followed by the docetaxel 3 days later. All patients will
undergo PET imaging prior to treatment and on Day 22.
Patients achieving a clinical response or stable disease as determined by physical
examination and/or traditional restaging studies (using established RECIST criteria) after
one 4 week cycle of therapy are eligible to receive continued cycles of SGN-15 and docetaxel
on the same schedule until clinical or radiographic disease progression or toxicity occurs.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
|University of Chicago||Chicago, Illinois 60637|
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231|
|Kaiser Permanente||Portland, Oregon 97227|
|Providence Health System, Regional Cancer Program||Portland, Oregon 97213|