OptiTROP-Lung03 Trial Part II Data
Description
Part II of the OptiTROP-Lung03 trial (NCT05631262) is a phase 2, open label, randomised controlled trial to compare sac-TMT with docetaxel for EGFR-mutated locally advanced or metastatic NSCLC with disease progression after previous treatment with EGFR-tyrosine kinase inhibitors and platinum based chemotherapy. Tumour assessments were conducted according to the RECIST (response evaluation criteria in solid tumours) version 1.1, with evaluations performed every six weeks during the first 48 weeks after randomisation and every 12 weeks thereafter. The primary endpoint was BIRC assessed objective response rate, defined as the proportion of patients with a confirmed complete response or partial response as the best overall response. This multicentre, randomised controlled trial found statistically significant improvements in objective response rate, progression-free survival, and overall survival with sac-TMT compared with docetaxel in patients with EGFR-mutated locally advanced or metastatic NSCLC, with a manageable safety profile. This study provides evidence supporting sac-TMT as an effective treatment for these patients with disease progression after treatment with EGFR-tyrosine kinase inhibitors and platinum based chemotherapy. The dataset includes: ID data of patients，random date, baseline ECOG score, histology, clinical stage, random group, last alive date, date of death, best confirmed efficacy assessed by BIRC , adverse events related to the investigational drug, drug-related serious adverse events, and PT terms for adverse events of grade 3 or higher related to the study drug.
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Study detailes are available at: https://clinicaltrials.gov/study/NCT05631262 Study results are available at: Fang, Wenfeng, et al. "Sacituzumab tirumotecan versus docetaxel for previously treated EGFR-mutated advanced non-small cell lung cancer: multicentre, open label, randomised controlled trial." bmj 389 (2025).
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Funding
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.