Tests sutetinib in lung cancer with uncommon EGFR gene changes
Tests sutetinib capsules in adults with advanced lung cancer and uncommon EGFR mutations.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC
Key facts
- Where
- Beijing, Chengdu, Guangzhou, Hangzhou, Harbin, Jinan, Nanchang, Nanjing, Qujing, Shanghai, Wuhan, and Zhengzhou, ChinaSee the 14 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-small cell lung cancer that is locally advanced or has spread, and whose tumor has an uncommon EGFR mutation.
- Age
- 18 years and older
- Sex
- Men and women can join.
- Disease stage
- Non-small cell lung cancer that is locally advanced or metastatic, confirmed by tissue or cell examination. At least one measurable lesion.
- Earlier treatment
- Cohort 1: no earlier EGFR TKI treatment. Cohort 2: no earlier second generation EGFR TKI. No anti-tumor therapy within 3 weeks, immunotherapy within 4 weeks, or traditional Chinese medicines for the tumor within 2 weeks.
- Biomarker or test result
- The tumor has an uncommon EGFR mutation, confirmed by a tumor tissue biopsy.
Main reasons for not taking part
- Active central nervous system metastases
- Active infection that is not under control
- Cannot swallow the study drug, or has a stomach or bowel condition that affects absorption
- Surgery on main organs or a significant injury within 4 weeks
- Strong CYP3A4 inhibitor or inducer drugs or foods within 14 days or 5 half-lives, whichever is longer
Read by machine on 9 November 2026.
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
- Beijing Chest HospitalBeijing, ChinaTaking people
- West China Hospital，Sichuan UniversityChengdu, ChinaTaking people
- Affiliated Cancer Hospital and Institute of Guangzhou Medical UniversityGuangzhou, ChinaTaking people
- Zhejiang Cancer HospitalHangzhou, ChinaTaking people
- Harbin Medical University Cancer HospitalHarbin, ChinaTaking people
- Jinan Central HospitalJinan, ChinaTaking people
- Jiangxi Cancer HospitalNanchang, ChinaTaking people
- Jiangsu Cancer HospitalNanjing, ChinaTaking people
- Qujing Central Hospital of Yunnan ProvinceQujing, ChinaTaking people
- Shanghai East HospitalShanghai, ChinaTaking people
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
- Henan Cancer HospitalZhengzhou, ChinaTaking people
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Teligene US
- Trial code
- NCT06010329
- Record updated
- 2 November 2026
- Original description
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).Read full original descriptionShow less
A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Uncommon EGFR Mutations Only)
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).
Inclusion: Age 18 years old and above, 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.
Exclusion: Use or intake of drugs or foods containing potent inhibitors or inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever is 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 National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAEv5.0) Grade 1, at the time of screening except for alopecia; Inability to swallow the study medication, any seriously (NCI-CTCAEv5.0 ≥ Grade 3) chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption; Any active infection which has not been controlled at screening; Other exclusion criteria apply for participating in the Study; Participant ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR TKI) for anti-tumor therapy prior to enrollment (Cohort 1), or second generation EGFR TKI (Cohort 2); Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion >30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for the tumor within 2 weeks prior to enrollment; Cohort 2: any EGFR TKIs within 5 half-lives; Active central nervous system metastases.