Phase 2
N=172
Study of Tecemotide (L-BLP25) in Participants With Stage III Unresectable Non-small Cell Lung Cancer (NSCLC) Following Primary Chemoradiotherapy
Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00960115 ↗Enrolled (actual)
172
Serious AEs
21.1%
Results posted
Oct 2015
Primary outcome: Primary: Overall Survival (OS) Time — 32.4; 32.2 Months — p=0.828
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tecemotide (L-BLP25) (Biological); Single low dose cyclophosphamide (Drug); Placebo (Biological); Saline (Other)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) Time |
32.4; 32.2 | 0.828 |
| SECONDARY Time To Progression (TTP) - Investigator Read |
11.3; 7.0 | — |
| SECONDARY Progression Free Survival (PFS) Time - Investigator Read |
11.6; 8.0 | — |
| SECONDARY Time to Treatment Failure (TTF) |
8.0; 6.2 | — |
Summary
This is a phase I/II study in Japan to evaluate the safety of EMD531444 and its effects on survival time in patients with stage III unresectable non-small cell lung cancer.
Eligibility Criteria
Inclusion Criteria
- Receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of greater than or equal to (>=) 50 Gray (Gy). Participant must have completed the primary thoracic chemoradiotherapy at least 4 weeks and no later than 12 weeks prior to randomization
- Written informed consent given before any study-related activities are carried out.
- Histologically or cytologically documented unresectable stage III NSCLC. Cancer stage must be confirmed and documented by Computed Tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) scan
- Documented stable disease or objective response, according to RECIST, after primary chemoradiotherapy for unresectable stage III disease, within four weeks prior to randomization
- Receipt of concomitant or sequential chemoradiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of >= 50 Gy
- Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow function
- Greater than or equal to 20 years of age
Exclusion Criteria
- Lung cancer-specific therapy (including surgery), other than primary chemoradiotherapy. Note: exploratory surgery before study entry is allowed
- Immunotherapy (e.g., interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) received within four weeks prior to randomization
- Malignant pleural/pericardial effusion or pleural dissemination or separate tumor nodules in the same lobe at initial diagnosis and/or at study entry
- Past or current history of neoplasm other than lung carcinoma, except for adequately 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 five years
- Autoimmune disease
- A recognized immunodeficiency disease including cellular immunodeficiencies, hypogamma-globulinemia, or dysgammaglobulinemia; participants who have hereditary or congenital/acquired immunodeficiencies
- Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy, including presence of diffuse radiation pneumonitis spreading out of the involved field
- Known Hepatitis B and/or C
- Clinically significant hepatic dysfunction
- Clinically significant renal dysfunction
- Clinically significant cardiac disease
- Splenectomy
- Infectious process that, in the opinion of the investigator, could compromise the subject's ability to mount an immune response
- Pregnant or breast-feeding women. Participants whom the investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard. Male and female subjects who have a reproductive ability, unless using effective contraception as determined by the investigator throughout the study until at least 6 months after the last study treatment
- Known drug abuse or alcohol abuse
- Legal incapacity or limited legal capacity
Data sourced from ClinicalTrials.gov (NCT00960115). 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.