Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer
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)
1 other identifier
interventional
99
2 countries
26
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Sep 2022
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2021
CompletedFirst Posted
Study publicly available on registry
December 23, 2021
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
April 28, 2026
April 1, 2026
5.3 years
December 12, 2021
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of Objective response rate (ORR)
Objective response rate (ORR) assessed by IRC
2 Years
Secondary Outcomes (11)
Assessment of Duration of response (DoR)
2 Years
Assessment of Disease control rate (DCR)
2 Years
Assessment of Progression free survival (PFS)
2 Years
Assessment of Time to progressive disease
2 Years
Assessment of Time to response
2 Years
- +6 more secondary outcomes
Study Arms (1)
Sutetinib Maleate Arm
EXPERIMENTALSutetinib capsules monotherapy
Interventions
Study drug to be taken orally with or without food (with food preferred) for up to13 cycles
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for anti-tumor therapy prior to enrollment.
- Any systemic anti-tumor therapy such as chemotherapy, immunotherapy and radiation therapy used within 4 weeks prior to enrollment; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for tumor within 2 weeks prior to enrollment.
- Use or intake of drugs or foods containing potent inhibitor or inducer of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever was the longer, prior to enrollment.
- Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment.
- Any unresolved toxicities from prior therapy greater than Grade 1 at the time of screening except alopecia.
- Inability to swallow the study medication, any seriously chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption.
- Active central nervous system metastases
- Previous or current interstitial lung disease, radiation pneumonitis which requires hormone therapy, or drug-related pneumonia, idiopathic interstitial pulmonary fibrosis identified in a baseline CT scan; uncontrolled massive pleural or pericardial effusion.
- Any active infection which has not been controlled at screening.
- Any serious cardiovascular disease.
- History of other serious systemic disease not suitable for clinical trial.
- Participation in other interventional clinical trial 4 weeks prior to enrollment or within 5 half-lives from the last dose of investigational product (whichever is longer).
- Known alcohol or drug dependence.
- Mental disorders or poor compliance.
- Previously received solid organ transplantation or hematopoietic stem cell transplantation.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teligene USlead
Study Sites (26)
OPN Healthcare, Inc.
Glendale, California, 91203, United States
University Cancer & Blood Center
Athens, Georgia, 30607, United States
Baptist Health
Louisville, Kentucky, 40223, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 230000, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Beijing Chest Hospital
Beijing, Beijing Municipality, 101125, China
The Affiliated Cancer Hospital of Chongqin University
Chongqing, Chongqing Municipality, 400044, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150086, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Wuhan Union Hospital of China
Wuhan, Hubei, 430000, China
Hunan Cancer Hospital
Changsha, Hunan, 410006, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
The First Affiliated Hospital of China Medical University
Shengyang, Liaoning, 830000, China
Linyi Cancer Hospital
Linyi, Shangdong, 276001, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200052, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200437, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610044, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2021
First Posted
December 23, 2021
Study Start
September 1, 2022
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share