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A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease.

Phase 3
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

Thank you

Trial Information

A Multi-center Phase III Randomized, Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease.

Ancillary Trial: An exploratory investigation of immune response in peripheral blood after
L-BLP25 (or placebo) vaccination.

The ancillary study is a sub-study within START. This is a exploratory investigation of the
immune response in peripheral blood after L-BLP25 (or placebo) vaccination. The main
objective is to evaluate whether administration of single-shot, low-dose cyclophosphamide
followed by L-BLP25 vaccinations induces specific immune response in peripheral blood to
BLP25 as well as a modulation of cellular and soluble components of the immune response in
patients with unresectable stage III NSCLC.

Twenty-five of the European START sites will participate in the ancillary study.

Sample size: up to 60 to 80 patients

All inclusion criteria specified in the START clinical trial protocol except for hemoglobin
≥ 100g/L

All exclusion criteria are the same as specified in the START clinical trial protocol

Schedule of events: Blood samples will be taken at baseline, visit week 4, 8 13 and 25 (80mL
whole blood each)

Inclusion Criteria:

- Histologically or cytologically documented unresectable stage III NSCLC.

- Documented stable disease or objective response, according to RECIST, after primary
chemoradiotherapy (either sequential or concomitant) for unresectable stage III
disease, within 4 weeks (28 days) prior to randomization.

- Receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of
two cycles of platinum-based chemotherapy and a minimum radiation dose of ≥ 50 Gy.
Subjects must have completed the primary thoracic chemo-radiotherapy at least four
weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects
who received prophylactic brain irradiation as part of primary chemo-radiotherapy are

- Geographically accessible for ongoing follow-up, and committed to comply with the
designated visits.

- An ECOG performance status of 0-1.

- A Platlet count > 140 x 10(9)/L; WBC > 2.5 x 10(9)/L and hemoglobin > 90 g/L.

Exclusion Criteria:

- Pre-Therapies:

- Undergone lung cancer specific therapy (including surgery) other than primary

- Receipt of immunotherapy (e.g. interferons, tumor necrosis factor [TNF],
interleukins, or biological response modifiers [granulocyte macrophage colony
stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF},
macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within 4
weeks (28 days) prior to randomization.

- Receipt of investigational systemic drugs (including off-label use of approved
products) within 4 weeks (28 days) prior to randomization.

- Disease Status:

- Metastatic disease

- Malignant pleural effusion at initial diagnosis and/or at study entry.

- Past or current history of neoplasm other than lung carcinoma, except for
curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or
other cancer curatively treated and with no evidence of disease for at least 5

- Autoimmune disease.

- A recognized immunodeficiency disease including cellular immunodeficiencies,
hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or
congenital immunodeficiencies.

- Any preexisting medical condition requiring chronic steroid or immunosuppressive
therapy (steroids for the treatment of radiation pneumonitis are allowed).

- Known Hepatitis B and/or C.

- Physiological Functions:

- Clinically significant hepatic dysfunction.

- Clinically significant renal dysfunction.

- Clinically significant cardiac disease.

- Splenectomy.

- Infectious process that in the opinion of the investigator could compromise the
subject's ability to mount an immune response.

- Standard Safety:

- Pregnant or breast-feeding women, women of childbearing potential, unless using
effective contraception as determined by the investigator.

- Known drug abuse/alcohol abuse.

- Legal incapacity or limited legal capacity

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To compare survival duration of all randomized subjects by treatment arm

Outcome Time Frame:

Interim analysis at 353 + 529 events (deaths); Final analysis at 705 events (deaths)

Safety Issue:


Principal Investigator

Frances Shepherd, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Oncology Princess Margaret Hospital, 610 University Avenue, 5-104, Toronto, ON M5G 2M9A, Canada


United States: Food and Drug Administration

Study ID:

EMR 63325-001



Start Date:

December 2006

Completion Date:

September 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Carcinoma;
  • stage III;
  • unresectable;
  • vaccine; Stimuvax; L-BLP25;
  • Cyclophosphamide;
  • placebo controlled;
  • randomized;
  • double blind;
  • immunotherapy;
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Colorado Cancer Center Denver, Colorado  80262
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Sinai Hospital of Baltimore Baltimore, Maryland  21225
University Hospitals of Cleveland Cleveland, Ohio  44106
Rush University Medical Center Chicago, Illinois  60612-3824
St. Vincents Comprehensive Cancer Center New York, New York  10011
Deaconess Billings Clinic Billings, Montana  59107-5100
Providence Portland Medical Center Portland, Oregon  97213-3635
Lahey Clinic Burlington, Massachusetts  01805
Gabrail Cancer Center Canton, Ohio  44718
Hematology and Oncology Specialists, LLC New Orleans, Louisiana  70115
The Center for Cancer and Blood Disorders Fort Worth, Texas  76104
Glendale Adventist Medical Center Glendale, California  91206
Joliet Oncology-Hematology Associates, Ltd. Flossmoor, Illinois  60422
Saint Edward Mercy Medical Center Ft. Smith, Arkansas  72903
Wheeling Hospital Wheeling, West Virginia  26003
Clinical Trials and Research Associates, Inc. Montebello, California  60460
Southeast Nebraska Cancer Center Lincoln, Nebraska  68510
Desert Hematology Oncology Medical Group, Inc Rancho Mirage, California  92270
Florida Hospital Memorial System Ormond Beach, Florida  32174
Pacific Cancer Medical Center Anaheim, California  92801
Pasco Hernando Oncology Associates, PA New Port Richey, Florida  34642
Oncology Care Associates St Joseph, Michigan  49085
University of Miami, Sylvester Comprehensive Cancer Center Miami, Florida  33136
Cancer Therapy & Research Center, Institute for Drug Development San Antonio, Texas  78229
The Jones Clinic, Pc Germantown, Tennessee  38138
Cedars-Sinai Outpatient Cancer Center at the Samuel Oschin Comprehensive Cancer Institute Los Angeles, California  90048
Norris Cancer Hospital Los Angeles, California  90033
Stockton Hematology Oncology Medical Group, Inc. Stockton, California  95204
Pasco Hernando Oncology Associates P.A Brooksville, Florida  34613
Southern Illinois Hematology/Oncology Centralia, Illinois  62801
Kentucky Cancer Center Hazard, Kentucky  41701
Leonard J. Chabert Medical Center Houma, Louisiana  
University of Maryland, Marlene and Steward Greenbaum Cancer Center Baltimore, Maryland  
University of Minnesota Physicians, Masonic Cancer Center Minneapolis, Minnesota  
Saint Louis University Cance Center Saint Louis, Missouri  
Big Sky Oncology, Sletten Cancer Institute Great Falls, Montana  59405
Nebraska Cancer Care, LLC Hastings, Nebraska  68901
Hematology Oncology Associates of Rockland Nyack, New York  10960
Univ. of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina  27599
Carolinas Hematology-Oncology Charlotte, North Carolina  28203
Hanover Medical Specialts PA Wilmington, North Carolina  28401
Signal Point Clinical Research Center, LLC Middletown, Ohio  45042
Southwestern Regional Medical Center Tulsa, Oklahoma  74133
Univ. of Pennsylvania Abramson Cancer Center Philadelphia, Pennsylvania  19104
Center for Oncology Research Dallas, Texas  75230
John Peter Smith Center for Cancer Care Fort Worth, Texas  76104
Fairfax-Northern Virginia Hematology Oncology, PC Fairfax, Virginia  22031