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May 29, 2026Journal of Clinical Oncology

Safety and efficacy of APS03118, a next-generation RET inhibitor, in patients with non-small cell lung cancer (NSCLC): Results from a phase I clinical trial.

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Authors

SLShun LuZZZhen ZhouQWQiming Wang

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Overview

Phase I trial evaluates efficacy and safety of APS03118 in RET fusion-positive NSCLC, indicating favorable outcomes.

Key Points

  • This study aims to evaluate the safety, tolerability, and efficacy of APS03118 in patients with advanced RET fusion-positive NSCLC.
  • Phase I clinical trial with 108 patients enrolled across multiple centers.
  • Patients received oral APS03118 ranging from 40 mg once daily to 120 mg twice daily.
  • Efficacy assessed using RECIST v1.1 every 2 cycles; safety evaluated via CTCAE v5.
  • Objective Response Rate (ORR) was 80% in evaluable treatment-naïve patients.
  • Median Progression-Free Survival (mPFS) not reached in patients receiving up to 16 cycles.
  • Grade ≥3 Treatment-Related Adverse Events (TRAEs) occurred in 50.9% of patients.

Cite This Study

Lu et al. (2026) studied this question.

synapsesocial.com/papers/6a192e79fab5b468c44178dfhttps://doi.org/10.1200/jco.2026.44.16_suppl.8617
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