Lung Cancer, Non-Small Cell Clinical Trial
Official title:
GSK2302032A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
The purpose of this study was to test a potential new kind of anti-cancer treatment, called
PRAME immunotherapy in resected patients with lung cancer.
Based on scientific and medical relevance, the clinical study was ended on 24 August 2016.
The participants were no longer enrolled in the study, the follow ups on subjects were
stopped and the collection and analysis of samples for further research purposes was stopped.
After the stop to recruitment, the study was unblinded, as per the amended protocol, the
study treatment was continued and completed with the subjects of the active treatment group
who were willing to continue. Subjects in the placebo group were withdrawn.
There was no longer an active follow-up of patients after discontinuation or completion of
the treatment. The study ended 30 days after the last dose was administered.
As a result, primary and secondary objectives were not assessed as planned. All clinical and
safety data collected in the study were analysed descriptively. For each biological sample
already collected in the scope of this study and not tested yet, testing was not performed by
default, except if a scientific rationale remained relevant despite the premature termination
of the study.
During the treatment period, safety monitoring continued as initially foreseen. Reporting of post-study adverse events (AEs) and serious AEs (SAEs) continued as per protocol. In the best interest of the patient, no more biological samples for protocol research purposes (i.e. serum sampling for humoral immunity, whole blood sampling for pharmacogenetics) were taken. ;
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