Phase 2b Randomized Controlled Study of Tecemotide (L-BLP25) for Immunotherapy of NSCLC (Non-Small Cell Lung Cancer)

This study has been completed.
Information provided by (Responsible Party):
Merck KGaA Identifier:
First received: September 8, 2005
Last updated: October 19, 2015
Last verified: October 2015
This is a prospective open label, controlled, randomized study to test the safety and efficacy of active specific immunotherapy with tecemotide (L-BLP25) for the treatment of subjects with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC). To be eligible, subjects entering the trial will have to demonstrate either stable disease or a clinical response after first-line treatment (chemotherapy alone, or chemotherapy and radiotherapy) and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Following a 3 week washout period, subjects will be stratified by disease status (either Stage IIIB locoregional disease or Stage IIIB with malignant pleural effusion and Stage IV), and randomized to either best supportive care (BSC) plus tecemotide (L-BLP25) treatment or BSC alone.

Condition Intervention Phase
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Biological: Tecemotide (L-BLP25)
Drug: Single low dose cyclophosphamide
Other: Best Supportive Care (BSC)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Phase IIb Randomised, Controlled Study of BLP25 Liposome Vaccine for Active Specific Immunotherapy of Non-Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs With Cancer and Leukemia Group B (CALGB) Toxicity Grade 3 or 4 [ Time Frame: From the first dose of study drug administration until 30 days after the last dose of study drug administration or assessed until cut-off date (15 March 2006) ] [ Designated as safety issue: Yes ]
    An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with TEAEs, serious TEAEs, TEAEs leading to death, and TEAEs with CALGB toxicity Grade 3 or 4 were reported.

  • Overall Survival Time [ Time Frame: Time from randomization to death or last day known to be alive, reported between day of first participant randomized that is, 08 August 2000, up to cut-off (15 March 2006) ] [ Designated as safety issue: No ]
    Time from randomization to death or last day known to be alive. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (15 March 2006), whichever was earlier.

Secondary Outcome Measures:
  • Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score [ Time Frame: At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study. ] [ Designated as safety issue: No ]
    Functional Assessment of Cancer Therapy - Lung cancer (FACT-L) is a valid instrument used to measure quality of life (QoL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0="not at all" and 4=equals "very much"). FACT-L total score=4 subscales + LCS and ranges from 0 to 144. Higher scores indicate better QOL.

  • Number of Participants With Positive T-cell Proliferation [ Time Frame: Time from randomization until cut-off date (15 March 2006) ] [ Designated as safety issue: No ]
    T-cell proliferation assays were performed and the number of participants with positive mucinous glycoprotein 1 (MUC1) specific T-cell proliferative response were reported.

  • Number of Participants With Elevated CA27-29 Antigen Levels [ Time Frame: Study entry, Week 8 ] [ Designated as safety issue: No ]
    CA 27-29 is a blood test used to monitor certain types of cancer. CA 27-29 is the name of an antigen, which is a substance that stimulates your body's defense system. CA27-29 antigen levels were determined on all participants and assessed the disease burden of participants at study entry, evaluated early recurrence, presence of residual disease, continued remission or poor prognosis.

Enrollment: 171
Study Start Date: August 2000
Study Completion Date: July 2012
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tecemotide (L-BLP25) plus Best Supportive Care (BSC) Biological: Tecemotide (L-BLP25)
After receiving single low dose cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at weeks 0, 1, 2, 3, 4, 5, 6 and 7 followed by maintenance vaccinations (1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from the study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of the investigator, and in case of unavailability of study vaccine.
Drug: Single low dose cyclophosphamide
A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment.
Other: Best Supportive Care (BSC)
The BSC will be provided at the investigator's discretion, and may include palliative radiation, psychosocial support, analgesics and nutritional support. Second-line chemotherapy is permitted when indicated for treatment of progressive disease.
Active Comparator: Best Supportive Care (BSC) Alone Other: Best Supportive Care (BSC)
The BSC will be provided at the investigator's discretion, and may include palliative radiation, psychosocial support, analgesics and nutritional support. Second-line chemotherapy is permitted when indicated for treatment of progressive disease.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stage IIIB or Stage IV NSCLC
  • Stable disease or a clinical response following first-line treatment, consisting of either chemotherapy alone or chemotherapy and radiotherapy. Subjects must have completed the first-line treatment at least 3 weeks prior to study entry
  • Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to (>=) 2
  • Ability to understand and willingness to sign a written informed consent
  • Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

  • Received immunotherapy within 4 weeks prior to study entry
  • Received immunosuppressive drugs within 3 weeks prior to study entry
  • Subjects with known brain metastases
  • 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 years
  • Autoimmune disease or immunodeficiency
  • Clinically significant hepatic, renal or cardiac dysfunction
  • Subjects with clinically significant active infection
  • Pregnant or breast feeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
  • Other protocol-defined exclusion criteria could apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00157209

Please Contact the Merck KGaA Communication Center
Darmstadt, Germany
Sponsors and Collaborators
Merck KGaA
Study Director: Medical Responsible Merck KGaA
  More Information

Butts C, Maksymiuk A, Goss G, et al. A multi-centre phase IIB randomized controlled study of BLP25 liposome vaccine (L-BLP25 or Stimuvax) for active specific immunotherapy of non-small cell lung cancer (NSCLC): updated survival analysis. J Thoracic Oncol. 2007 Aug; 2(8), Suppl 4, S332-3.
Butts C, Anderson H, Maksymiuk A, et al. Long-term safety of BLP25 liposome vaccine (L-BLP25) in patients (pts) with stage IIIB/IV non-small cell lung cancer (NSCLC). J Clin Onc 2009; 27(15S): abstract 3055.

Responsible Party: Merck KGaA Identifier: NCT00157209     History of Changes
Other Study ID Numbers: B25-LG-304 / EMR 63325-005
Study First Received: September 8, 2005
Results First Received: July 23, 2015
Last Updated: October 19, 2015
Health Authority: Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 27, 2015