Primary endpoints to assess the efficacy of novel therapeutic approaches in epidermal growth factor receptor-mutated, surgically resectable non-small cell lung cancer: A review

Collin M Blakely,Walter Weder,Lukas Bubendorf,Jianxing He,Margarita Majem,Yu Shyr,Jamie E Chaft

Lung Cancer（2023）

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摘要

•Treatments are limited in early-stage resectable NSCLC with targetable alterations.•In this setting, long overall survival follow-up can delay regulatory approvals.•Clinically relevant and validated surrogate endpoints can accelerate trial readout.•Further prospective validation data are needed for new surrogate primary endpoints.•A collaborative effort is needed to allow rapid assessment of targeted treatments.

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关键词

ALK,amiva,atezo,beva,carbo,CCG,cis,CNS,CT,ctDNA,dabra,DFS,DoR,EFS,EGFR,EGFRm,EGFR-TKI,EMA,EORTC-QLQ-C30/LC13,FACT-L,FDA,FFPE,gem,HRQoL,IASLC,ipi,KRAS,MAA,MET,MPR,MRD,nivo,NSCLC,NSCLC-SAQ,NTRK,ORR,OS,pCR,PD-L1,pem,PFS,PFS2,PK,pt CT,QoL,ReSEEM,tram,SF-36v2,TTP,vino

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