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

Phase 2

Completed

Conditions: Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Interventions: Biological: Tecemotide (L-BLP25)
Drug: Single low dose cyclophosphamide
Other: Best Supportive Care (BSC)

Registration Number: NCT00157209

Lead Sponsor: Merck KGaA, Darmstadt, Germany

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 171

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tecemotide (L-BLP25) plus Best Supportive Care (BSC)	Single low dose cyclophosphamide	-
Tecemotide (L-BLP25) plus Best Supportive Care (BSC)	Best Supportive Care (BSC)	-
Tecemotide (L-BLP25) plus Best Supportive Care (BSC)	Tecemotide (L-BLP25)	-
Best Supportive Care (BSC) Alone	Best Supportive Care (BSC)	-

Primary Outcome Measures

Name	Time	Method
Overall Survival Time	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)	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.
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	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)	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.

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy (FACT-L) Questionnaire Score	At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study.	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 from randomization until cut-off date (15 March 2006)	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	Study entry, Week 8	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.