A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 in Completely Resected Non-Small Cell Lung Cancer (BR31)

Conditions

Completely resected primary stage IB (≥ 4cm), II and IIIA non-small cell lung cancer patients

Brief summary

Disease free survival (DFS) for patients with NSCLC that is PD-L1 expression TC ≥ 25% and EGFR-/ALK-.

Detailed description

DFS in the remaining 5 patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status., Overall survival (OS) for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status., Lung cancer specific survival for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status., Adverse effects and tolerability of MEDI4736., Quality of life in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status., Survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile., Economic evaluation (cost effectiveness and cost utility)., Evaluation of predictive/prognostic significance of PD-L1 expression., Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event., Exploratory pharmacogenomic assays (baseline only).

Related papers

No related papers found yet.

Interventions

DRUGMEDI4736 Placebo

DRUGDURVALUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease free survival (DFS) for patients with NSCLC that is PD-L1 expression TC ≥ 25% and EGFR-/ALK-.	—

Secondary

Measure	Time frame
DFS in the remaining 5 patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status., Overall survival (OS) for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status., Lung cancer specific survival for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status., Adverse effects and tolerability of MEDI4736., Quality of life in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status., Survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile., Economic evaluation (cost effectiveness and cost utility)., Evaluation of predictive/prognostic significance of PD-L1 expression., Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event., Exploratory pharmacogenomic assays (baseline only).	—

Measure

Time frame

DFS in the remaining 5 patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status., Overall survival (OS) for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status., Lung cancer specific survival for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status., Adverse effects and tolerability of MEDI4736., Quality of life in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status., Survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile., Economic evaluation (cost effectiveness and cost utility)., Evaluation of predictive/prognostic significance of PD-L1 expression., Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event., Exploratory pharmacogenomic assays (baseline only).

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Countries

Bulgaria, France, Hungary, Italy, Netherlands, Poland, Romania, Spain

Outcome results

None listed