Clinical trial · Interventional
Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best standard of care (BSC) | Other | — | UNRESOLVED |
| Single low dose cyclophosphamide | Drug | — | UNRESOLVED |
| Tecemotide (L-BLP25) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tecemotide(L-BLP25)+Cyclophosphomide+best standard of care
- interventionNames
- Biological: Tecemotide (L-BLP25)
- Drug: Single low dose cyclophosphamide
- Other: Best standard of care (BSC)
Primary outcomes (1)
- measure
- 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)
- timeFrame
- Up to data cut-off date (17 September 2007)
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Other protocol defined inclusion criteria could apply Exclusion Criteria: * 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 * Other protocol defined inclusion criteria could apply
References
Publications (1)
- RESULTButts 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 21071331