START ? Stimulating Targeted Antigenic Responses To NSCLC. A multi-center phase III randomized, double-blind placebo-controlled study of the cancer vaccine Stimuvax(L-BLP25 or BLP25 liposome vaccine)in non-small cell lung cancer (NSCLC) subjects with unresectable stage III disease. - START

Conditions: on-small cell lung cancer(NSCLC)subjects with unresectable stage III disease who demonstrated stable disease or objective response after primary chemo-radiotherapy (concomitant or sequential).
MedDRA version: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer

Registration Number: EUCTR2006-000579-14-IT

Lead Sponsor: Merck KgAa

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1322

Inclusion Criteria

Both inpatient or out patient,male and female subjects are eligible for randomization. Subject has given written informed consent before any study-related activities are carried out. Histologically or cytologically documented unresectable stage III NSCLC. All histological subtypes are acceptable,including bronchioalveolar carcinomas. 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 chemo-radiotherapy(either sequential or concomitant)for unresectable stage III disease,within 4 weeks(28 days)prior to randomization*. Receipt of concomitant or sequential chemo-radiotherapy, consisting of a minimum of two cycles of platinum-based chemotherapy and a minimum radiation dose of≥50Gy. Subjects must have completed the primary thoracic chemo-radiotherapy at least four weeks(28 days)and no later than 12 weeks(84 days)prior to randomization. Subjects who received prophylactic brain irradiation as part of primary chemo-radiotherapy are eligible. Geographically accessible for ongoing follow-up, and committed to comply with the designated visits. An ECOG performance status of 0-1. A platelet count ≥100x109/L;WBC≥2.5x109/L and hemoglobin≥90g/L. >18 years of age. *If imaging after primary chemo-radiotherapy was earlier than 4weeks prior to randomization,it must be repeated within 4weeks prior to randomization,and the results of the second restaging after end of primary chemo-radiotherapy must be compared with the first restaging after end of primary chemo-radiotherapy. Subjects that show progression between these two assessments are not eligible for this trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

ExclusionCriteria: Pre-Therapies: Undergone lung cancer specific therapy(including surgery)other than primary chemo-radiotherapy. Receipt of 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)within 4weeks(28 days)prior to randomization. Note: Subjects who have received monoclonal antibodies for imaging are acceptable. Receipt of investigational systemic drugs(including off-label use of approved products)within 4 weeks(28 days)prior to randomization. Disease Status: Metastatic disease. Malignant pleural effusion at initial diagnosis and at study entry. 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 that in the opinion of the investigator could compromise the safety of the subject in this study. A recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies. Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy(steroids for the treatment of radiation pneumonitis are allowed). Known Hepatitis B and/or C

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective:to compare survival duration of all randomized subjects by treatment arm.;Secondary Objective: Secondary objectives of this trial are to compare all randomized subjects by treatment arm for:Time to symptom progression(TTSP)as measured by the Lung Cancer Symptom Scale(LCSS).Time to progression(TTP)as determined by the investigator.One-,two-and three-year survival. Safety.;Primary end point(s): The primary end point of this study is the survival duration. Survival will be measured as the number of months between the date of randomization and the date of death.

Secondary Outcome Measures