Tecemotide Following Concurrent Chemo-radiotherapy for Non-small Cell Lung Cancer (START2)
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|ClinicalTrials.gov Identifier: NCT02049151|
Recruitment Status : Terminated (The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC)
First Posted : January 30, 2014
Results First Posted : March 30, 2017
Last Update Posted : August 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Tecemotide Drug: Placebo Drug: Cyclophosphamide (CPA) Drug: Saline (sodium chloride)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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)|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Tecemotide injection will be administered once weekly subcutaneously at a dose of 806 microgram up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.
Drug: Cyclophosphamide (CPA)
CPA injection will be administered as a single intravenous infusion at a dose of 300 milligram per square meter (mg/m^2) (to a maximum of 600 mg) 3 days before the first injection of tecemotide.
|Placebo Comparator: Placebo||
Matching placebo injection will be administered once weekly subcutaneously up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.
Drug: Saline (sodium chloride)
Matching placebo (saline) injection will be administered as a single intravenous (0.9 percent [%] sodium chloride) infusion 3 days before the first injection of tecemotide-matching placebo.
- Overall Survival [ Time Frame: Time from date of randomization until death, assessed maximum up to 16 months ]Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects.
- Time to Symptom Progression (TTSP) [ Time Frame: Time from date of randomization until progressive disease (PD), assessed up to 16 months ]TTSP was measured from date of randomization to date of disease progression (defined based on RECIST v1.1), 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 quality of life (QoL) for individuals undergoing treatment for lung cancer. Subject scale was used as a tool to determine TTSP. It was a 9-item questionnaire used to document subject-reported outcomes for a variety of lung cancer associated symptoms. The average symptomatic burden index (ASBI) was used to determine differences in the treatment groups. ASBI was the mean of the 6 symptom scores derived from the LCSS questionnaire. Symptom progression was 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.
- Progression Free Survival (PFS) [ Time Frame: Time from date of randomization until PD or death, assessed up to 16 months ]PFS was defined as the time from date of randomization until date of the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Subjects without event were censored on the date of last tumor assessment.
- Time to Progression (TTP) [ Time Frame: Time from date of randomization until PD, assessed up to 16 months ]TTP was measured from the date of randomization to the date of tumor progression. Date of tumor progression was 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 was calculated and used as a censored observation in the analysis. Subjects dying from causes other than PD was censored at time of death.
- Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI-CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs) [ Time Frame: Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months ]An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of Subjects With TEAEs, Serious TEAEs, NCI-CTC Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, and ISRs were reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049151
|United States, Massachusetts|
|Please Contact U.S. Medical Information Located in|
|Rockland, Massachusetts, United States|
|Please contact the Merck KGaA Communication Center Located in|
|Study Director:||Medical Responsible||Merck KGaA, Darmstadt, Germany|