A Multicenter, Open-label, Phase IIb Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Non-resistant Uncommon EGFR Mutations Only, Including L861Q, G719X, and/or S768I)
Who is this study for? Patients with locally advanced or metastatic NSCLC with non-resistant uncommon EGFR mutations
What treatments are being studied? Sutetinib Maleate
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
OPN Healthcare, Inc.
RECRUITING
Glendale
Georgia
University Cancer & Blood Center
RECRUITING
Athens
Kentucky
Baptist Health
RECRUITING
Louisville
Maryland
University of Maryland Medical Center
RECRUITING
Baltimore
North Carolina
FirstHealth Cancer Center
RECRUITING
Pinehurst
Texas
The University of Texas- MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
China
Beijing Cancer Hospital
ACTIVE_NOT_RECRUITING
Beijing
Beijing Chest Hospital
ACTIVE_NOT_RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
ACTIVE_NOT_RECRUITING
Beijing
Peking Union Medical College Hospital
ACTIVE_NOT_RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
ACTIVE_NOT_RECRUITING
Bengbu
Jilin Cancer Hospital
ACTIVE_NOT_RECRUITING
Changchun
Hunan Cancer Hospital
ACTIVE_NOT_RECRUITING
Changsha
Sichuan Cancer Hospital
ACTIVE_NOT_RECRUITING
Chengdu
The Affiliated Cancer Hospital of Chongqin University
ACTIVE_NOT_RECRUITING
Chongqing
The First Affiliated Hospital of Guangzhou Medical University
ACTIVE_NOT_RECRUITING
Guangzhou
Zhejiang Cancer Hospital
ACTIVE_NOT_RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
ACTIVE_NOT_RECRUITING
Harbin
Linyi Cancer Hospital
ACTIVE_NOT_RECRUITING
Linyi
Jiangsu Province Hospital
ACTIVE_NOT_RECRUITING
Nanjing
Shanghai Chest Hospital
ACTIVE_NOT_RECRUITING
Shanghai
Shanghai Pulmonary Hospital
ACTIVE_NOT_RECRUITING
Shanghai
The First Affiliated Hospital of China Medical University
ACTIVE_NOT_RECRUITING
Shengyang
Wuhan Union Hospital of China
ACTIVE_NOT_RECRUITING
Wuhan
Henan Cancer Hospital
ACTIVE_NOT_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University