Further study details as provided by Canadian Cancer Trials Group:
Primary Outcome Measures:
- Compare Disease free survival (DFS) for patients with NSCLC that is PD-L1 positive [ Time Frame: 5.5 years ]
Secondary Outcome Measures:
- Compare Disease Free Survival in all randomized patients [ Time Frame: 7 years ]
Compare overall survival (OS) for patients with NSCLC that is PD-L1 positive [ Time Frame: 5.5 years ]
Compare overall survival for all randomized patients [ Time Frame: 7 years ]
Compare Lung cancer specific survival for patients with NSCLC that is PD-L1 positive and all randomized patients [ Time Frame: 7 years ]
Evaluate the nature, severity and frequency of adverse effects and tolerability of MEDI4736 [ Time Frame: every 6 months ]
All patients who receive at least one dose of MEDI4376/placebo will be included in the safety analysis. Descriptive summary tables will be presented on safety parameters by treatment arm. There will be safety monitoring by the NCIC CTG Data Safety Monitoring Committee (DSMC) every 6 months
Evaluate the Quality of life between the two treatment arms in PD-L1+ patients and in all randomized patients. [ Time Frame: 5.5 years ]
The quality of life (QoL) of patients will be assessed using EORTC QLQ-C30 and the lung cancer module (QLQ-LC13) incorporated.
Determine survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile [ Time Frame: 5.5 years ]
Determine the incremental cost effectiveness and cost utility ratios for MEDI4736 [ Time Frame: 5.5 years ]
Evaluate the predictive/prognostic significance of PD-L1 expression [ Time Frame: 5.5 years ]
Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event [ Time Frame: 5.5 years ]
Explore polymorphisms that may be associated with outcomes [ Time Frame: Baseline only ]
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