Carcinoma, Non-Small-Cell Lung Clinical Trial
— START2Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of Tecemotide Versus Placebo in Subjects With Completed Concurrent Chemo-radiotherapy for Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated either stable disease or objective response following primary concurrent chemo-radiotherapy (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus subjects treated with tecemotide-matching placebo.
Status | Terminated |
Enrollment | 35 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Written informed consent, before any trial-related activities are carried out - Histologically or cytologically documented unresectable stage III NSCLC, including bronchioalveolar carcinomas. Cancer stage must be confirmed and documented by computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET) scan - Prior concurrent CRT which is defined as follows: - Minimum of 2 cycles of platinum-based chemotherapy - Radiotherapy with a total tumor dose greater than equal to (>=) 60 Gray and a single fraction dose >= 1.8 Gray - Overlap of radiotherapy with minimum 2 cycles of platinum-based chemotherapy (one cycle is defined as either 3 or 4 weeks depending on the chemotherapy regimen). A deviation of 2 to 3 days from an exact overlap is acceptable. Purely radiosensitizing doses of chemotherapy are not acceptable (for example [e.g.], daily low dose regimens; weekly carbo-platinum + paclitaxel regimens are allowed). - Subjects must have completed the primary thoracic CRT at least 4 weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary CRT are eligible. - Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, after primary concurrent CRT for unresectable stage III disease, within 4 weeks (28 days) prior to randomization - An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - A platelet count, white blood cells (WBC) and hemoglobin value as defined in the protocol - Male or female, greater than or equal to 18 years of age - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Undergone lung cancer specific therapy (including surgery) other than initial concurrent CRT - Received chemotherapy during radiotherapy in radiosensitizing doses only (e.g., daily low dose regimens; weekly carbo-platinum + paclitaxel regimens are allowed). - Metastatic disease - Malignant pleural effusion at initial diagnosis, during initial CRT, and/or at trial 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 - A recognized immunodeficiency disease including human immunodeficiency virus (HIV) infection and other cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, congenital or acquired immunodeficiencies - Splenectomy - Any preexisting medical condition requiring chronic systemic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed) - Receipt of immunotherapy (as defined in the protocol) within 4 weeks prior to randomization - Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks prior to randomization - Autoimmune disease - Active or chronic infectious hepatitis - Infectious process that, in the opinion of the Investigator, could compromise the subject's ability to mount an immune response - Clinically significant hepatic dysfunction, renal dysfunction and cardiac disease as defined in the protocol - Pregnant or breast-feeding women - Known drug abuse/alcohol abuse - Participation in another interventional clinical trial within the past 28 days (excluding purely observational studies) - Requires concurrent treatment with a non-permitted drug - Known hypersensitivity to any of the trial treatment ingredients - Legal incapacity or limited legal capacity - Any other reason that, in the opinion of the Investigator, precludes the subject from participating in the trial - Other protocol defined exclusion criteria could apply |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Please contact the Merck KGaA Communication Center Located in | Darmstadt | |
United States | Please Contact U.S. Medical Information Located in | Rockland | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
EMD Serono |
United States, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (OS) Time | OS time will be defined as the duration between the date of randomization and the date of death. For participants not known to be deceased at the time of analysis, the time from the date of randomization to the date of last contact, or date lost to follow-up, will be calculated and used as a censored observation in the analysis. | From the date of randomization up to 12- Week follow-up visit after the last dose of study treatment | No |
Secondary | Time to Symptom Progression (TTSP) | TTSP will be measured from date of randomization to date of progression, using the lung cancer symptom scale (LCSS), a validated questionnaire consisting of an observer scale and a subject scale used to specifically measure symptom changes relevant to QoL for individuals undergoing treatment for lung cancer. The subject scale will be used as a tool to determine TTSP. It is a 9-item questionnaire used to document subject-reported outcomes for a variety of lung cancer associated symptoms. The average symptomatic burden index (ASBI) will be used to determine differences in the treatment groups. ASBI is the mean of the 6 symptom scores derived from the LCSS questionnaire. Symptom progression will be defined as an increase (worsening) of the ASBI score of 10% of the scale breadth (10 mm on a scale of 0-100 mm) from the baseline score on at least 2 consecutive assessments during the period when assessments are performed every 3 weeks and every 6 weeks. | From the date of randomization up to 12- Week follow-up visit after the last dose of study treatment | No |
Secondary | Progression-free Survival (PFS) | PFS is defined as the time from randomization to the first documentation of progressive disease (PD) or to death due to any cause, whichever occurs first. PD is assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - Investigator read. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. For subjects alive without tumor progression at time of analysis, the time between date of randomization and the last date that imaging was performed will be used to calculate PFS time and used as a censored observation in the analysis. | From the date of randomization up to 12- Week follow-up visit after the last dose of study treatment | No |
Secondary | Time to Progression (TTP) | TTP will be measured from the date of randomization to the date of tumor progression. The date of tumor progression will be the date of radiological diagnosis of PD, performed as per RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. For participants alive without tumor progression at time of analysis, the time between date of randomization and date of last trial treatment will be calculated and used as a censored observation in the analysis. Participants dying from causes other than PD will be censored at time of death. | From the date of randomization up to 12- Week follow-up visit after the last dose of study treatment | No |
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