NCT00157196

Brief Summary

The primary objective is to document the safety of tecemotide (L-BLP25) phase III formulation in non-small cell lung cancer (NSCLC) subjects with unresectable Stage III disease. This population includes Stage IIIA NSCLC subjects, a population not studied in former clinical studies with this vaccine. The secondary objective is to document the survival of subjects treated.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

August 18, 2015

Completed
Last Updated

August 18, 2015

Status Verified

July 1, 2015

Enrollment Period

2.4 years

First QC Date

September 8, 2005

Results QC Date

July 23, 2015

Last Update Submit

July 23, 2015

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Keywords

Carcinoma, Non-Small-Cell Lung, L-BLP25, Tecemotide

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs With CALGB-ECTC Grade 3 or 4, TEAEs Leading to Discontinuation, TEAEs Leading to Death, and Injection Site Reactions (ISRs)

    TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE 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. TEAEs with Cancer and Leukemia Group B Extended Clinical Toxicity Criteria (CALGB-ECTC) Grade 3 or 4 were also reported.

    Up to data cut-off date (17 September 2007)

Secondary Outcomes (2)

  • Survival Time

    Up to data cut-off date (17 September 2007)

  • Progression Free Survival (PFS) Time

    Up to data cut-off date (17 September 2007)

Study Arms (1)

Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care

EXPERIMENTAL
Biological: Tecemotide (L-BLP25)Drug: Single low dose cyclophosphamideOther: Best standard of care (BSC)

Interventions

Tecemotide (L-BLP25)BIOLOGICAL

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 disease progression is documented.

Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care
Single low dose cyclophosphamideDRUG

A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment.

Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care
Best standard of care (BSC)OTHER

The BSC will be provided at the investigator's discretion, and may include but not be limited to psychosocial support, nutritional support and other supportive therapies.

Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically documented unresectable stage III NSCLC. Mediastinal (N2) involvement must be confirmed by biopsy
  • Stable disease or clinical response after primary therapy of chemo-radiation treatment for unresectable stage III disease
  • Primary therapy should be a minimum of 2 cycles of Platinum-based first-line chemotherapy, given concurrent with thoracic radiation. The combined modality should consist of either:
  • induction (2 cycles) chemotherapy followed by concurrent chemo-radiation therapy; or
  • concurrent chemo-radiation therapy followed by 2 cycles of consolidation chemotherapy; or
  • concurrent chemoradiation therapy alone
  • A minimum radiation dose of greater than or equal to (\>=) 6,000 centigray (cGy) should be administered. Subjects must have completed the primary therapy at least 4 weeks and no later than 6 months prior to study entry
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (\<=) 1
  • Ability to understand and willingness to sign a written informed consent

You may not qualify if:

  • Undergone lung cancer specific therapy (including surgery) prior to primary chemo-radiation therapy
  • Received immunotherapy/systemic immunosuppressive drugs/investigational systemic drugs within 4 weeks prior to study entry
  • Subjects with brain metastases, pleural effusion, unless cytologically confirmed to be non-malignant
  • 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 dysfunction or cardiac diseases
  • Clinically significant active infection
  • Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Butts C, Murray RN, Smith CJ, Ellis PM, Jasas K, Maksymiuk A, Goss G, Ely G, Beier F, Soulieres D. A multicenter open-label study to assess the safety of a new formulation of BLP25 liposome vaccine in patients with unresectable stage III non-small-cell lung cancer. Clin Lung Cancer. 2010 Nov 1;11(6):391-5. doi: 10.3816/CLC.2010.n.101.

    PMID: 21071331RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsCarcinoma

Interventions

L-BLP25Single PersonCyclophosphamide

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Results Point of Contact

Title
Merck KGaA Communication Center
Organization
Merck Serono, a division of Merck KGaA
service@merckgroup.com
+49-6151-72-5200

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 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

April 1, 2005

Primary Completion

September 1, 2007

Study Completion

April 1, 2012

Last Updated

August 18, 2015

Results First Posted

August 18, 2015

Record last verified: 2015-07