Study Comparing DZD9008 with Standard Chemotherapy for Advanced Non-Small Cell Lung Cancer

Sponsor: Dizal Pharmaceuticals

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05668988

Provider View

This clinical trial is testing a new drug, DZD9008, against standard chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation. The study aims to see which treatment is more effective in controlling the cancer.

Patient Parameters

Program Overview

This phase 3 study is comparing the effectiveness and safety of a new drug, DZD9008, with standard platinum-based chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) that has a specific mutation called EGFR Exon20ins. The study involves about 320 participants who will be randomly assigned to receive either DZD9008 or the standard chemotherapy. The main goal is to see which treatment helps patients live longer without the cancer getting worse.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old.
  • Have a confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC) that is advanced or has spread to other parts of the body and cannot be cured with surgery.
  • Have enough tumor tissue available for testing to confirm the specific EGFR mutation.
  • Have at least one tumor that can be measured by scans.
  • Expected to live at least 12 more weeks.
  • Be in good overall health, able to carry out normal activities or light work.
  • Have good organ and blood function as shown by medical tests.

Exclusion Criteria

  • Have received any previous treatment for advanced or metastatic NSCLC.
  • Have cancer that has spread to the spinal cord or the membranes surrounding the brain and spinal cord.
  • Have other specific EGFR mutations.
  • Have had a stroke or bleeding in the brain within the last 6 months.
  • Have severe or uncontrolled health conditions, such as high blood pressure or bleeding disorders.

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