Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer

NCT02049151 | Terminated Phase 3 Results DMC

• 2 other identifiers: EMR 63325-0212013-003760-30
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated either stable disease or objective response following primary concurrent chemo-radiotherapy (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus subjects treated with tecemotide-matching placebo.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell Lung; Tecemotide; Placebo; NSCLC; L-BLP25

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects.

  Time from date of randomization until death, assessed maximum up to 16 months

Secondary Outcomes (4)

• Time to Symptom Progression (TTSP)

  Time from date of randomization until progressive disease (PD), assessed up to 16 months

• Progression Free Survival (PFS)

  Time from date of randomization until PD or death, assessed up to 16 months

• Time to Progression (TTP)

  Time from date of randomization until PD, assessed up to 16 months

• Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI-CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs)

  Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months

Study Arms (2)

Tecemotide

EXPERIMENTAL

Drug: Tecemotide; Drug: Cyclophosphamide (CPA)

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: Saline (sodium chloride)

Interventions

Tecemotide DRUG

Tecemotide injection will be administered once weekly subcutaneously at a dose of 806 microgram up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.

Tecemotide

Placebo DRUG

Matching placebo injection will be administered once weekly subcutaneously up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.

Placebo

Cyclophosphamide (CPA) DRUG

CPA injection will be administered as a single intravenous infusion at a dose of 300 milligram per square meter (mg/m\^2) (to a maximum of 600 mg) 3 days before the first injection of tecemotide.

Tecemotide

Saline (sodium chloride) DRUG

Matching placebo (saline) injection will be administered as a single intravenous (0.9 percent \[%\] sodium chloride) infusion 3 days before the first injection of tecemotide-matching placebo.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent, before any trial-related activities are carried out
• Histologically or cytologically documented unresectable stage III NSCLC, including bronchioalveolar carcinomas. Cancer stage must be confirmed and documented by computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET) scan
• Prior concurrent CRT which is defined as follows:
• Minimum of 2 cycles of platinum-based chemotherapy
• Radiotherapy with a total tumor dose greater than equal to (\>=) 60 Gray and a single fraction dose \>= 1.8 Gray
• Overlap of radiotherapy with minimum 2 cycles of platinum-based chemotherapy (one cycle is defined as either 3 or 4 weeks depending on the chemotherapy regimen). A deviation of 2 to 3 days from an exact overlap is acceptable. Purely radiosensitizing doses of chemotherapy are not acceptable (for example \[e.g.\], daily low dose regimens; weekly carbo-platinum + paclitaxel regimens are allowed).
• Subjects must have completed the primary thoracic CRT at least 4 weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary CRT are eligible.
• Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, after primary concurrent CRT for unresectable stage III disease, within 4 weeks (28 days) prior to randomization
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• A platelet count, white blood cells (WBC) and hemoglobin value as defined in the protocol
• Male or female, greater than or equal to 18 years of age

You may not qualify if:

• Undergone lung cancer specific therapy (including surgery) other than initial concurrent CRT
• Received chemotherapy during radiotherapy in radiosensitizing doses only (e.g., daily low dose regimens; weekly carbo-platinum + paclitaxel regimens are allowed).
• Metastatic disease
• Malignant pleural effusion at initial diagnosis, during initial CRT, and/or at trial entry
• 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
• A recognized immunodeficiency disease including human immunodeficiency virus (HIV) infection and other cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, congenital or acquired immunodeficiencies
• Splenectomy
• Any preexisting medical condition requiring chronic systemic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed)
• Receipt of immunotherapy (as defined in the protocol) within 4 weeks prior to randomization
• Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks prior to randomization
• Autoimmune disease
• Active or chronic infectious hepatitis
• Infectious process that, in the opinion of the Investigator, could compromise the subject's ability to mount an immune response
• Clinically significant hepatic dysfunction, renal dysfunction and cardiac disease as defined in the protocol
• Pregnant or breast-feeding women

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (2)

Please Contact U.S. Medical Information Located in

Rockland, Massachusetts, United States

Location

Please contact the Merck KGaA Communication Center Located in

Darmstadt, Germany

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

L-BLP25; Cyclophosphamide; Sodium Chloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Sponsor discontinued development of tecemotide (L-BLP25) in NSCLC, hence the study was terminated.

Results Point of Contact

• Title: Merck KGaA Communication Centre
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

496151725200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 30, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 23, 2017
• Results First Posted: March 30, 2017

Record last verified: 2017-07

Locations

DE (1); US (1)