A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC
18 - 75 Years, Male and Female
TL-EGFR-2201 (primary)
NCI-2023-10529
Summary
The main objective of the study will be to evaluate the efficacy of sutetinib maleate
capsules in participants with locally advanced or metastatic non-small cell lung cancer
NSCLC (uncommon EGFR mutations only).
Objectives
Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a
gene that makes a protein that is involved in cell growth and cell survival. Mutated
(changed) forms of the EGFR gene and protein have been found in some types of cancer,
including non-small cell lung cancer. These changes may cause cancer cells to grow and
spread in the body. The purpose of this study is to explore how effective Sutetinib
maleate capsules are for the treatment of patients with locally advanced or metastatic
NSCLC with uncommon EGFR mutations.
Eligibility
- Age 18-75 years old, male or female
- Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC
- Confirmation that the tumor harbors an uncommon epidermal growth factor receptor (EGFR) mutation (tumor tissue biopsy)
- At least one measurable lesion
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
- A minimum life expectancy of > 3 months
- Adequate bone marrow reserve, hepatic, renal, and coagulation function Other inclusion criteria apply for participating in the study
Treatment Sites in Georgia
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