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Phase 2 N=172 Randomized Double-blind Treatment

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

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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