At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 22 enrolled

Drug / intervention

Tecemotide (L-BLP25) +2 morebiological

Likely dose

Tecemotide (L-BLP25) 1000 mcg subcutaneously: 8 weekly vaccinations (weeks 0-7) followed by maintenance vaccinations at 6-week intervals; single low-dose cyclophosphamide 300 mg/m² IV (maximum 600 mg) 3 days prior to first vaccineAI-extracted

Key inclusion· 6

✓Histologically documented unresectable stage III NSCLC with biopsy-confirmed mediastinal (N2) involvement
✓Stable disease or clinical response after primary therapy consisting of at least 2 cycles platinum-based chemotherapy concurrent with thoracic radiation
✓Primary therapy completed at least 4 weeks and no later than 6 months prior to study entry
✓Minimum radiation dose of ≥6000 cGy

Key exclusion· 8

✕Prior lung cancer-specific therapy (including surgery) before primary chemo-radiation
✕Immunotherapy, systemic immunosuppressive drugs, or investigational systemic drugs within 4 weeks prior to study entry
✕Brain metastases or pleural effusion (unless cytologically confirmed non-malignant)
✕History of other neoplasm except curatively treated non-melanoma skin cancer, in situ cervical carcinoma, or cancer with ≥5 years disease-free survival

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00157196

NCT00157196Phase 2Completed

Compare CT.gov

A Multi-center, Non-randomized, Open Label Safety Study of BLP25 Liposome Vaccine (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Patients With Unresectable Stage III Disease

Merck KGaA, Darmstadt, Germany·interventional·Posted Sep 12, 2005·Updated Aug 18, 2015

In Brief

A Phase 2 clinical trial evaluating Tecemotide (L-BLP25), Single low dose cyclophosphamide, and 1 other intervention for Carcinoma, Non-Small-Cell Lung and Lung Neoplasms. Completed, enrolled 22 participants.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCarcinoma, Non-Small-Cell Lung, Lung Neoplasms

Countries--

Collaborators--

Timeline

Phase 2CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2005

First PostedSep 2005

Primary CompletionSep 2007

Study CompletionApr 2012

TodayJul 2026

First PostedSep 12, 2005

Enrollment StartApr 1, 2005

Primary CompletionSep 1, 2007

Study CompletionApr 1, 2012

TodayJul 2, 2026

Enrollment to primary: 2.4 yearsPosted 20.8 years ago

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.

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.

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.