Study on Sutetinib Maleate Capsules for Advanced or Metastatic Non-small Cell Lung Cancer

Sponsor: Teligene US

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05168566

Provider View

This clinical trial is testing the safety and effectiveness of Sutetinib Maleate capsules in treating patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has specific uncommon EGFR mutations.

Patient Parameters

Program Overview

This study is exploring a new treatment called Sutetinib, which is designed to target and block a protein involved in the growth of cancer cells. The trial focuses on patients with advanced or metastatic non-small cell lung cancer (NSCLC) that have specific uncommon mutations in the EGFR gene. These mutations can cause cancer cells to grow and spread. The goal is to see how well Sutetinib works in controlling the cancer and to ensure it is safe for patients to use.

Description

Sutetinib is an experimental drug that targets a specific protein involved in cell growth, known as EGFR. In some cancers, including non-small cell lung cancer (NSCLC), changes in the EGFR gene can lead to uncontrolled cell growth. This study aims to determine how effective Sutetinib Maleate capsules are in treating patients with advanced or metastatic NSCLC that have specific uncommon EGFR mutations. The study will monitor the safety and effectiveness of the drug in shrinking tumors and controlling the disease.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older, male or female.
  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) with no more than one previous chemotherapy treatment.
  • The cancer must have specific uncommon EGFR mutations, such as L861Q, G719X, or S768I, confirmed by a tumor biopsy.
  • Have at least one tumor that can be measured by scans.
  • Be in relatively good health with an ECOG performance status of 0, 1, or 2.
  • Have a life expectancy of more than 3 months.
  • Have adequate bone marrow, liver, kidney, and blood clotting function.
  • Be willing to use effective birth control if of childbearing potential.

Exclusion Criteria

  • Have previously used EGFR-targeting drugs for cancer treatment.
  • Have received any cancer treatment, including chemotherapy, immunotherapy, or radiation, within 4 weeks before joining the study.
  • Have taken drugs or foods that strongly affect liver enzymes within 14 days before joining the study.
  • Have had major surgery or significant injury within 4 weeks before joining the study.
  • Have unresolved side effects from previous treatments, except for hair loss.
  • Cannot swallow pills or have serious digestive issues affecting absorption.
  • Have active cancer spread to the brain or spinal cord.
  • Have lung diseases requiring hormone therapy or uncontrolled fluid around the lungs or heart.
  • Have an active infection that is not controlled.
  • Have serious heart disease or other major health issues unsuitable for the trial.
  • Have participated in another clinical trial within 4 weeks before joining.
  • Have a history of alcohol or drug dependence.
  • Have mental health issues affecting compliance.
  • Have had organ or stem cell transplants.
  • Are pregnant or breastfeeding.
  • Have allergies to the study drug or its ingredients.
  • Have had another primary cancer within the last 3 years, except for certain low-risk cancers.

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