Trial Identifiers
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Scientific Title
A Phase 2 Trial of MRTX849 Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab Plus Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Commercial Sponsor
Mirati Therapeutics Inc.
Summary
This study is being conducted in two parts, and each part has multiple cohorts of participants.
The Phase II portion of the study will evaluate the efficacy and safety of MRTX849 as monotherapy and when given in combination with pembrolizumab. There will be 3 cohorts of participants, all of whom have KRAS G12C mutation, have advanced or metastatic non-small cell lung cancer (NSCLC), and are candidates for first-line treatment. 2 cohorts of people who have a PD-L1 TPS score of <1% and="" are="" randomised="" to="" receive="" either="" mrtx849="" as="" monotherapy="" or="" mrtx849="" in="" combination="" with="" pembrolizumab.="" the="" 3rd="" cohort="" will="" consist="" of="" people="" with="" pd-l1="" score="" of="" 1%="" or="" higher,="" and="" they="" will="" receive="" mrtx849="" +="" pembrolizumab.="" the="" phase="" iii="" portion="" of="" the="" study="" will="" randomise="" people="" with="" non-squamous="" nsclc="" with="" kras="" g12c="" mutation="" and="">1%><50% in="" the="" first-line="" setting="" to="" receive="" either="" mrtx849="" +="" pembrolizumab,="" or="" pembrolizumab="" +="" chemotherapy.="" **note:="" in="" april="" 2023,="" grampians="" health="" is="" recruiting="" only="" people="" with="" pd-l1="" tps="" of="">50%><>