Sponsor: Summit Therapeutics
Sponsor Study ID: AK112-301
Study Title: A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined with Pemetrexed and Carboplatin in Patients with EGFRmutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment (HARMONi)
CTO #: 103839
NCT Number: NCT06396065
Phase: III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Lung
Study Objectives: 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 non- squamous 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. 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.