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

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 2

Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Single low dose cyclophosphamide

Biological: Tecemotide (L-BLP25)

Other: Best Supportive Care (BSC)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00157209

B25-LG-304 / EMR 63325-005

Details and patient eligibility

About

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.

Enrollment

171 patients

Sex

All

Ages

18+ years old

Volunteers

No 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