Phase III Study of Lucanix™ (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer: An International Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Lucanix™ Maintenance Therapy for Stages III/IV NSCLC Subjects Who Have Responded to or Have Stable Disease Following One Regimen of Front-line, Platinum-based Combination Chemotherapy
Primary Efficacy Endpoints:
- Compare the overall survival of subjects with stage III or IV non-small cell lung
cancer treated with belagenpumatucel-L (Lucanix™) vs placebo.
Secondary Efficacy Endpoints:
- Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared
to treatment within the BSC control group.
- Evaluate the quality of life (QOL) as determined by the Lung Cancer Symptom Scale
(LCSS) compared to treatment within the BSC control group.
- Evaluate the time-to-progression of subjects treated with Lucanix™ compared to
treatment within the BSC control group.
- Evaluate the best overall tumor response in subjects treated with Lucanix™ compared to
treatment in the BSC control group.
- Evaluate the response duration in subjects treated with Lucanix™ compared to the BSC
- Evaluate the rate of CNS metastases development in subjects treated with Lucanix™ as
compared to the BSC control group.
- Adverse events of subjects treated with Lucanix™ will be compared to subjects in the
Outline: This is a multicenter study. Subjects are stratified according to disease stage
(IIIA vs IIIB or IV), response to prior treatment with front-line chemotherapy (stable
disease vs partial response or complete response), prior treatment with front-line
chemotherapy and radiotherapy (front-line chemotherapy with radiotherapy vs front-line
chemotherapy alone), and prior treatment with front-line chemotherapy and other anticancer
therapy (front-line chemotherapy with bevacizumab vs front-line chemotherapy alone or in
combination with another anticancer agent). Subjects are randomized to 1 of 2 treatment
- Treatment Arm: Subjects receive belagenpumatucel-L (Lucanix™) intradermally (ID) once
monthly for 18 months and then once at 21 and 24 months in the absence of disease
progression or unacceptable toxicity.
- Control Arm: Subjects receive placebo ID once monthly for 18 months and then once at
21 and 24 months in the absence of disease progression or unacceptable toxicity.
Blood samples are collected and analyzed for routine chemistry, cytokines, chemokines, and
some instances circulating tumor cells, including response to multiple lung
cancer-associated antigens by IFN-γ ELISPOT CD8+ assay; CEA by CD4 class II assay; lung
tumor-associated antigens by in vitro proliferation assays; regulatory T-cell (Treg)
phenotype by flow cytometry; and Treg function.
Subjects complete the Lung Cancer Symptom Scale quality of life questionnaire at baseline,
on the days of treatment, 30 days after completion of study treatment, and then every 3
months for 1 year.
After completion of study treatment, subjects are followed every 3 months for 1 year and
then annually for 4 years.
In two phase II trials, many subjects who received Lucanix™ at the same dose that will be
administered in this trial had long-term disease stability with a good quality of life.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo.
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|James Graham Brown Cancer Center||Louisville, Kentucky 40202|
|University of Tennessee Cancer Institute||Memphis, Tennessee 38103|
|Comprehensive Cancer Centers of Nevada||Las Vegas, Nevada 89109|
|Cancer Center at Hackensack University Medical Center||Hackensack, New Jersey 07601|
|Alaska Regional Hospital||Anchorage, Alaska 99508|
|Comprehensive Blood and Cancer Center||Bakersfield, California 93309|
|Atlanta Cancer Care||Atlanta, Georgia 30342|
|Henry Ford Health System||Detroit, Michigan 48202|
|University of Colorado Health Science Center||Aurora, Colorado 80010-0510|
|Ocala Oncology||Ocala, Florida 34474|
|University of California, San Diego||La Jolla, California 92037-1709|
|Cancer Care Associates||Fresno, California 93720|
|Santa Barbara Hematology Oncology Medical Group, Inc.||Santa Barbara, California 93105|
|Eastchester Center for Cancer Care||Bronx, New York 10469|
|Cancer Center of the Carolinas||Greenville, South Carolina 29615|
|Hematology Oncology Life Center||Alexandria, Louisiana 71301|
|Cancer Care of WNC||Asheville, North Carolina 28801|
|Marshfield Clinic Weston Center||Weston, Wisconsin 54476|
|Central Coast Medical Oncology Corporation||Santa Maria, California 93454|
|University of Minnesota Medical Center||Minneapolis, Minnesota 55455|
|Kootenai Cancer Center||Post Falls, Idaho 83854|
|Richmond University Medical Center||Staten Island, New York 10310-1699|
|Pasco Hernando Oncology Associates, P.A.||14529 Cortez Blvd., Florida 34613|
|Southern Cancer Center||Mobile, Alabama 36608|
|Mary Crowley Cancer Research Centers||Dallas, Texas 75201|
|Sansum Clinic||Santa Barbara, California 93105|
|University of Tennessee Cancer Institute||Southaven, Mississippi 38671|
|Mayo Clinic Cancer Center||Scottsdale, Arizona 85259|
|Clopton Clinic Hematology/Oncology||Jonesboro, Arkansas 72401|
|UCLA Pasadena Oncology||Pasadena, California 91105|
|Innovative Research Center of California||San Diego, California 92103|
|UCLA Cancer Center||Santa Monica, California 90404|
|UCLA Cancer Center-Valencia||Valencia, California 91355|
|Medical Specialist of Palm Beaches||Lake Worth, Florida 33467|
|Space Coast Medical Center||Titusville, Florida 32796|
|St. Francis Medical Group Oncology and Hematology Specialists||Indianapolis, Indiana 46237|
|Iowa Blood and Cancer Center||Cedar Rapids, Iowa 52402|
|National Cancer Institute Center for Cancer Research, Medical Oncology Branch||Bethesda, Maryland 20892-1182|
|Allergy Partners of West North Carolina||Asheville, North Carolina 28801|
|Gabrail Cancer Center Research LLC||Canton, Ohio 44718|
|Optim Oncology||Midwest City, Oklahoma 73110|
|Texas Cancer Center Abilene, Texas Oncology P.A.||Abilene, Texas 79606|
|Allison Cancer Center, Texas Oncology, P.A.||Midland, Texas 79701|
|Tyler Cancer Center, Texas Oncology||Tyler, Texas 75702|
|Seattle Cancer Care Alliance/Fred Hutchinson Cancer Res Ctr/Univ. of Washington Med Ctr||Seattle, Washington 98109|
|Davis Memorial Cancer Care Center||Elkins, West Virginia 26241|