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A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy

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Trial Profile

A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 05 Jun 2025

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At a glance

  • Drugs Zipalertinib (Primary)
  • Indications Non-small cell lung cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Acronyms REZILIENT1
  • Sponsors Cullinan Therapeutics

Most Recent Events

  • 01 Jun 2025 According to a Taiho Pharmaceutical media release, company announced the publication of positive results from the REZILIENT1 trial in the peer-reviewed Journal of Clinical Oncology (JCO).
  • 29 May 2025 According to a Taiho Pharmaceutical media release, data from the study will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL and will participate in the Jefferies 2025 Global Healthcare Conference, being held June 3-5, 2025 in New York, NY.
  • 22 May 2025 According to a Taiho Pharmaceutical media release, as of the Dec 2024 data cutoff, 244 patients were enrolled in REZILIENT1 and received at least one dose of 100 mg zipalertinib.

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