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

• Register: EUCTR
• Last refreshed on: 22 December 2015
• Main ID: EUCTR2013-003760-30-IE
• Date of registration: 07/03/2014
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA
• Public title: Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer
• Scientific title: A multicenter, randomized, double-blind, placebo-controlled phase III trial of tecemotide versus placebo in subjects with completed concurrent chemo-radiotherapy for unresectable stage III non-small cell lung cancer (NSCLC)
• Date of first enrolment: 22/05/2014
• Target sample size: 1002
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003760-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Austria, Belarus, Belgium, Canada, Chile, Czech Republic, Denmark, France, Germany, Ireland, Italy, Kuwait, Mexico, Netherlands, New Zealand, Oman, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States

Contacts

• Name: Communication Centre Merck KGaA
• Affiliation: Merck KGaA

• Name: Communication Centre Merck KGaA
• Affiliation: Merck KGaA

Key inclusion & exclusion criteria

Inclusion criteria:
1) Written informed consent, before any trial-related activities are carried out.
2) 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.
3) Prior concurrent CRT which is defined as follows:
- Minimum of 2 cycles of platinum-based chemotherapy.
- Radiotherapy with total tumor dose = 60 Gray (Gy) and a single fraction dose = 1.8 Gy.
- 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).
4) 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
5) An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6) A platelet count, white blood cells (WBC) and hemoglobin value as defined in the protocol.
7) Male or female,
8) 18 years of age or over.
Other protocol defined inclusion criteria could apply.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 637
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 365

Exclusion criteria:
1) Undergone lung cancer specific therapy (including surgery) other than initial concurrent CRT.
2) Received chemotherapy during radiotherapy in radiosensitizing doses only.
3) Metastatic disease.
4) Malignant pleural effusion at initial diagnosis, during initial CRT, and/or at trial entry.
5) Past or current history of neoplasm other than lung carcinoma, except for curatively treated nonmelanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
6) 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.
7) Splenectomy.
8) Any preexisting medical condition requiring chronic systemic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed).
9) Receipt of immunotherapy (as defined in the protocol) within 4 weeks prior to randomization.
10) Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks (28 days) prior to randomization.
11) Autoimmune disease.
12) Active or chronic infectious hepatitis.
13) Infectious process that, in the opinion of the investigator, could compromise the subject’s ability to mount an immune response.
14) Clinically significant hepatic dysfunction, renal dysfunction and cardiac disease as defined in the protocol.
15) Clinically significant hepatic dysfunction, renal dysfunction and cardiac disease as defined in the protocol.
16) Clinically significant cardiac disease, e.g., New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or
uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an ECG.
17) Pregnant or breast-feeding women (for details see
Inclusion Criteria).
18) Known drug abuse/alcohol abuse.
19) Participation in another interventional clinical trial within the past 28 days (excluding purely observational studies).
20) Requires concurrent treatment with a non-permitted drug.
21) Known hypersensitivity to any of the trial treatment ingredients.
22) Legal incapacity or limited legal capacity.
23) Any other reason that, in the opinion of the investigator, precludes the subject from participating in the trial


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

unresectable stage III non-small cell lung cancer (NSCLC)
MedDRA version: 18.1 Level: LLT Classification code 10025052 Term: Lung cancer non-small cell stage III System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: L-BLP25
Product Code: EMD531444
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: tecemotide
CAS Number: 420086-91-5
Current Sponsor code: BLP25
Other descriptive name: BLP25 lipopeptide
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 403-
Pharmaceutical form of the placebo: Powder for suspension for injection
Route of administration of the placebo: Intravenous use

Trade Name: Endoxana Injection 1g
Product Name: Endoxana Injection 1g
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CYCLOPHOSPHAMIDE
CAS Number: 50-18-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Primary Outcome(s)

Secondary Objective: - Time to symptom progression (TTSP) as measured by the Lung Cancer Symptom Scale (LCSS).
- Progression-free survival (PFS) time.
- Time to progression (TTP).
- Safety.

Primary end point(s): Overall Survival (OS) time. OS time will be measured from the date of randomization to the date of death or up to 5 years, whichever is first.

Main Objective: To compare overall survival (OS) time by treatment arm.

Timepoint(s) of evaluation of this end point: up to 5 years or date of death, whichever is first

Secondary Outcome(s)

Secondary end point(s): - TTSP as measured by the LCSS.
- PFS time as determined by the investigator.
- TTP as determined by the investigator.
- Number of Subjects With Adverse Events (AEs), Serious AEs, treatment emergent AEs, AEs leading to death, and AEs with National Cancer Institute-Common Toxicity Criteria (NCI-CTC) toxicity Grade 3 or 4 and Injection site reactions (ISRs)
- Number of subjects with clinically significant abnormal Electrocardiogram (ECG) and lab parameters

Timepoint(s) of evaluation of this end point: Baseline up to 12 weeks after the last dose administration

Secondary ID(s)

EMR63325-021

2013-003760-30-CZ

Source(s) of Monetary Support

Merck KGaA