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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: 13 May 2026

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At a glance

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

Most Recent Events

  • 28 Apr 2026 According to a Taiho Pharmaceutical media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for zipalertinib for the treatment of with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027.
  • 08 Jan 2026 According to a Cullinan Therapeutics media release, the company expects to complete Zipalertinib rolling NDA submission in Q1 2026.
  • 20 Nov 2025 According to a Taiho Pharmaceutical media release, The companies anticipate completion of the NDA submission in the first quarter of 2026 with an associated request for priority review.

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