Study on Zipalertinib for Advanced Non-Small Cell Lung Cancer with Specific EGFR Mutations

Sponsor: Taiho Oncology, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05967689

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, zipalertinib, for patients with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes in the EGFR gene.

Patient Parameters

Program Overview

The purpose of this study is to see if zipalertinib is safe and works well for treating patients with advanced non-small cell lung cancer (NSCLC) that has certain changes in the EGFR gene, known as ex20ins mutations or other uncommon mutations. The study will include patients who have not responded to previous treatments or have specific conditions related to their cancer.

Description

This study is divided into four groups based on the type of EGFR mutation and previous treatments:

  • Cohort A: Patients with EGFR ex20ins mutations who have already tried standard chemotherapy and another treatment targeting ex20ins mutations but their cancer has progressed.
  • Cohort B: Patients with EGFR ex20ins mutations who have not yet received treatment for their advanced cancer.
  • Cohort C: Patients with EGFR ex20ins or other uncommon mutations who have active brain metastases, regardless of previous treatments.
  • Cohort D: Patients with other uncommon EGFR mutations who have tried standard treatments but their cancer has progressed.

The study will assess how well zipalertinib works and its safety in these different groups of patients.

Eligibility Criteria

Inclusion Criteria

  • Must provide written informed consent.
  • Be 18 years or older.
  • Have a confirmed diagnosis of advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations.
  • For Cohort A: Must have EGFR ex20ins mutation and have progressed after previous treatments.
  • For Cohort B: Must have EGFR ex20ins mutation and not have received prior treatment for advanced cancer.
  • For Cohort C: Must have EGFR ex20ins or other uncommon mutations and active brain metastases.
  • For Cohort D: Must have other uncommon EGFR mutations and have progressed after previous treatments.
  • Must have measurable disease according to specific criteria.
  • Must provide a tumor tissue sample for testing.
  • Must have a performance status indicating good overall health.
  • Must have adequate organ function based on lab tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 6 months after.
  • Men and women must agree to use effective birth control during the study and for 6 months after.

Exclusion Criteria

  • Currently participating in another clinical trial or receiving an investigational drug.
  • Have received zipalertinib before.
  • Have had recent radiation therapy, immunotherapy, or major surgery.
  • Have unresolved side effects from previous cancer treatments.
  • Have a history of certain lung diseases or heart problems.
  • Cannot swallow pills or have conditions affecting drug absorption.
  • Have had another cancer within the last 2 years, unless it meets specific criteria.
  • Have uncontrolled hepatitis B, hepatitis C, or HIV.
  • Have had a recent COVID-19 infection with ongoing symptoms.
  • Have active bleeding disorders.
  • Are allergic to zipalertinib or similar drugs.
  • Are pregnant or breastfeeding.

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