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- AK112-301-HARMONi
Lung cancer
AK112-301-HARMONi
A randomized, double-blind, multi-center, Phase III Study of AK112 or placebo combined with;pemetrexed and carboplatin in patients with EGFR-mutant locally advanced or metastatic nonsquamous;NSCLC who have failed to EGFR-TKI treatment.
- Open at Paris since : 22/01/2024
- Target : Adult
- Phase : Phase III
Trial description
To compare overall survival (OS) in the Modified Intent-to-Treat (mITT) population;between AK112 combined with pemetrexed and carboplatin and placebo combined;with pemetrexed and carboplatin, in patients with locally advanced or metastatic nonsquamous;non-small cell lung cancer (NSCLC) with epidermal growth factor receptor;(EGFR) mutations who have progressed on or following EGFR tyrosine kinase;inhibitor (TKI) therapy.;À To compare progression-free survival (PFS) assessed by the Independent Radiology;Review Committee (IRRC) based on Response Evaluation Criteria in Solid Tumors;(RECIST) v1.1, in the mITT population between AK112 combined with pemetrexed;and carboplatin and placebo combined with pemetrexed and carboplatin, in patients;with locally advanced or metastatic non-squamous NSCLC with EGFR mutations who;have progressed on or following EGFR TKI therapy
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