Phase 2
N=22
Safety Study of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease
Carcinoma, Non-Small-Cell Lung · Lung Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00157196 ↗Enrolled (actual)
22
Serious AEs
18.2%
Results posted
Aug 2015
Primary outcome: Primary: 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) — 22; 4; 13; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tecemotide (L-BLP25) (Biological); Single low dose cyclophosphamide (Drug); Best standard of care (BSC) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
22; 4; 13; 1; 11 | — |
| SECONDARY Survival Time |
NA | — |
| SECONDARY Progression Free Survival (PFS) Time |
NA | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00157196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.