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

Primary Purpose

Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Tecemotide (L-BLP25)
Single low dose cyclophosphamide
Best Supportive Care (BSC)
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Please Contact the Merck KGaA Communication Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tecemotide (L-BLP25) plus Best Supportive Care (BSC)

Best Supportive Care (BSC) Alone

Arm Description

Outcomes

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
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 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
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
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
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.

Full Information

First Posted
September 8, 2005
Last Updated
October 19, 2015
Sponsor
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00157209
Brief Title
Phase 2b Randomized Controlled Study of Tecemotide (L-BLP25) for Immunotherapy of NSCLC (Non-Small Cell Lung Cancer)
Official Title
A Multicenter Phase IIb Randomised, Controlled Study of BLP25 Liposome Vaccine for Active Specific Immunotherapy of Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tecemotide (L-BLP25) plus Best Supportive Care (BSC)
Arm Type
Experimental
Arm Title
Best Supportive Care (BSC) Alone
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Tecemotide (L-BLP25)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Single low dose cyclophosphamide
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Best Supportive Care (BSC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
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)
Title
Overall Survival Time
Description
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.
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)
Secondary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score
Description
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.
Time Frame
At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study.
Title
Number of Participants With Positive T-cell Proliferation
Description
T-cell proliferation assays were performed and the number of participants with positive mucinous glycoprotein 1 (MUC1) specific T-cell proliferative response were reported.
Time Frame
Time from randomization until cut-off date (15 March 2006)
Title
Number of Participants With Elevated CA27-29 Antigen Levels
Description
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.
Time Frame
Study entry, Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Please Contact the Merck KGaA Communication Center
City
Darmstadt
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16170175
Citation
Butts C, Murray N, Maksymiuk A, Goss G, Marshall E, Soulieres D, Cormier Y, Ellis P, Price A, Sawhney R, Davis M, Mansi J, Smith C, Vergidis D, Ellis P, MacNeil M, Palmer M. Randomized phase IIB trial of BLP25 liposome vaccine in stage IIIB and IV non-small-cell lung cancer. J Clin Oncol. 2005 Sep 20;23(27):6674-81. doi: 10.1200/JCO.2005.13.011.
Results Reference
result
PubMed Identifier
21744082
Citation
Butts C, Maksymiuk A, Goss G, Soulieres D, Marshall E, Cormier Y, Ellis PM, Price A, Sawhney R, Beier F, Falk M, Murray N. Updated survival analysis in patients with stage IIIB or IV non-small-cell lung cancer receiving BLP25 liposome vaccine (L-BLP25): phase IIB randomized, multicenter, open-label trial. J Cancer Res Clin Oncol. 2011 Sep;137(9):1337-42. doi: 10.1007/s00432-011-1003-3. Epub 2011 Jul 9.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

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

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