Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Analgesics

Vaccines

Cyclophosphamide

Immunomodulating Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

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.

Tecemotide (L-BLP25)

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.

Single low dose cyclophosphamide

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.

Best Supportive Care (BSC)

Medical Responsible

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.

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

A Multicenter Phase IIb Randomised, Controlled Study of BLP25 Liposome Vaccine for Active Specific Immunotherapy of Non-Small Cell Lung Cancer

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 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.

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.

T-cell proliferation assays were performed and the number of participants with positive mucinous glycoprotein 1 (MUC1) specific T-cell proliferative response were reported.

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.

Merck KGaA, Darmstadt, Germany

A serious adverse event was an AE that resulted in any of the following outcomes: death, life threatening, persistent/significant disability/incapacity, initial or prolonged inpatient hospitalization, congenital anomaly/birth defect.

A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 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 with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from 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 investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.

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

The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.

Best Supportive Care (BSC) Alone

Total

Age, Continuous

Sex: Female, Male

Baseline analysis population included all randomized participants.

Merck KGaA Communication Center

TEAEs

Serious TEAEs

TEAEs leading to death

TEAEs with CALGB toxicity Grade 3 or 4

Analysis population included all participants randomized in the study.

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

Analysis population included all randomized participants.

Overall Survival Time

Baseline (n=88, 78)

Week 4 (n=86, 75)

Week 8 (n=84, 73)

Week 19 (n=54, 55)

Week 31(n=34, 36)

Week 43 (n=31, 20)

Analysis population included all the participants with a baseline and at least one post-baseline complete FACT-L questionnaire. "n" signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively.

Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score

Analysis population included all randomized participants. "N" signifies total number of participants who were evaluable for this measure. T-cell measure was done only on arm A where subjects received tecemotide for induction of t-cell response. Therefore arm B BSC did not have any samples taken for this assessment.

Number of Participants With Positive T-cell Proliferation

Study entry (n=84, 82)

Week 8 (n=82, 71)

Analysis population included all randomized participants. "n" signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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