Actively Recruiting
Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer
Led by Teligene US · Updated on 2026-04-28
99
Participants Needed
26
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years old and above, male or female.
- Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC with no more than 1 prior chemotherapy line.
- Tumor confirmed to have non-resistant uncommon EGFR mutations (L861Q, G719X, and/or S768I) excluding other EGFR sensitive mutations or oncogenes.
- At least one measurable tumor lesion.
- ECOG performance status of 0, 1, or 2.
- Life expectancy greater than 3 months.
- Adequate bone marrow, liver, kidney, and blood clotting function.
- Willingness to use acceptable birth control methods if of childbearing potential.
You will not qualify if you...
- Prior use of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for cancer treatment.
- Use of chemotherapy, immunotherapy, radiation therapy within 4 weeks before enrollment; palliative radiotherapy or certain traditional medicines within 2 weeks.
- Use of drugs or foods affecting cytochrome P450 3A4 enzyme within 14 days or 5 half-lives before enrollment.
- Major surgery or significant injury within 4 weeks before enrollment.
- Unresolved side effects from previous treatments greater than Grade 1, except hair loss.
- Difficulty swallowing study medication or serious gastrointestinal disorders.
- Active brain metastases.
- Interstitial lung disease, radiation pneumonitis needing hormone therapy, drug-related pneumonia, idiopathic pulmonary fibrosis, or uncontrolled fluid buildup around lungs or heart.
- Uncontrolled infections at screening.
- Serious heart diseases.
- Other serious systemic diseases unsuitable for clinical trial.
- Participation in another clinical trial within 4 weeks or 5 half-lives from last investigational drug dose.
- Known alcohol or drug dependence.
- Mental disorders or poor study compliance.
- Previous solid organ or stem cell transplantation.
- Pregnancy or breastfeeding.
- Known allergy to study drug or ingredients.
- Other primary cancers within 3 years except low-risk types.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
OPN Healthcare, Inc.
Glendale, California, United States, 91203
Actively Recruiting
2
University Cancer & Blood Center
Athens, Georgia, United States, 30607
Actively Recruiting
3
Baptist Health
Louisville, Kentucky, United States, 40223
Withdrawn
4
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
5
FirstHealth Cancer Center
Pinehurst, North Carolina, United States, 28374
Actively Recruiting
6
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Active, Not Recruiting
7
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 230000
Active, Not Recruiting
8
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Active, Not Recruiting
9
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Active, Not Recruiting
10
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Active, Not Recruiting
11
Beijing Chest Hospital
Beijing, Beijing Municipality, China, 101125
Active, Not Recruiting
12
The Affiliated Cancer Hospital of Chongqin University
Chongqing, Chongqing Municipality, China, 400044
Active, Not Recruiting
13
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510230
Active, Not Recruiting
14
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150086
Active, Not Recruiting
15
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Active, Not Recruiting
16
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Active, Not Recruiting
17
Wuhan Union Hospital of China
Wuhan, Hubei, China, 430000
Active, Not Recruiting
18
Hunan Cancer Hospital
Changsha, Hunan, China, 410006
Active, Not Recruiting
19
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Active, Not Recruiting
20
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Active, Not Recruiting
21
The First Affiliated Hospital of China Medical University
Shengyang, Liaoning, China, 830000
Active, Not Recruiting
22
Linyi Cancer Hospital
Linyi, Shangdong, China, 276001
Active, Not Recruiting
23
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200052
Active, Not Recruiting
24
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200437
Active, Not Recruiting
25
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610044
Active, Not Recruiting
26
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Active, Not Recruiting
Research Team
X
Xiaoyang Xia
CONTACT
D
Dawei Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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