Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer
18 Years and older, Male and Female
SZCT-2020-06 (primary)
NCI-2022-04928
Summary
This is a Phase 2b, multicenter, open-label study to evaluate the safety and efficacy of
Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon
EGFR Mutations Only, Including L861Q, G719X, and/or S768I)
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 non-resistant uncommon EGFR mutations
Eligibility
- Age 18 years old and above, male or female.
- Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC patients with = 1 prior line of chemotherapy.
- Confirmation that the tumor harbors a non-resistant uncommon EGFR mutation (tumor tissue biopsy), including one or more of L861Q, G719X and S768I mutations, excluding any other EGFR sensitive mutations and/or oncogenes..
- At least one measurable lesion.
- ECOG score of 0, 1, or 2.
- A minimum life expectancy of > 3 months.
- Adequate bone marrow reserve, hepatic, renal and coagulation function.
- Willingness of all subjects of childbearing potential to use acceptable methods of birth control.
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