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April 19, 2026Cancer Research0 citations

Evaluating EP0031 as Monotherapy and with Chemotherapy in Advanced RET-Fusion-Positive NSCLC

Abstract CT213: A phase I/II study to evaluate EP0031 (lunbotinib), a next-generation selective RET inhibitor, as monotherapy and in combination with chemotherapy, in patients with advanced RET-fusion-positive NSCLC

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Authors

JRJaime RubioEGElena GarraldaBBBenjamin Besse

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Overview

Phase I/II trial evaluates EP0031’s effectiveness in advanced RET-fusion-positive NSCLC, suggesting a potential combined treatment approach.

Key Points

  • The study aims to assess the safety and efficacy of EP0031, a selective RET inhibitor, both alone and in combination with chemotherapy in RET-fusion-positive NSCLC.
  • Ongoing phase I/II trial recruiting patients with advanced RET-fusion-positive NSCLC.
  • Monotherapy RP2D of EP0031 determined at 90 mg daily with chemotherapy cohorts receiving standard doses for four cycles.
  • Endpoints include tumor response by RECIST v1.1, progression-free survival, overall survival, safety, and pharmacokinetics.
  • EP0031 showed activity in patients previously untreated with selective RET inhibitors.
  • Synergy confirmed between EP0031 and chemotherapy in preclinical studies.
  • Ongoing monitoring of safety and incidence of dose-limiting toxicities during combination treatment.

Cite This Study

Rubio et al. (2026) studied this question.

synapsesocial.com/papers/69e47376010ef96374d8f453https://doi.org/10.1158/1538-7445.am2026-ct213
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