Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Drug: Sutetinib Maleate Capsule
- Registration Number
- NCT05168566
- Lead Sponsor
- Teligene US
- 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)
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 99
- Age 18 years old and above, male or female.
- Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC patients with β€ 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.
- 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.
- Females who are pregnant or breastfeeding.
- Known hypersensitivity to the active ingredients or excipients of the investigational product.
- Have any other primary malignant tumors within 3 years (except some low- risk cancers).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sutetinib Maleate Arm Sutetinib Maleate Capsule Sutetinib capsules monotherapy
- Primary Outcome Measures
Name Time Method Assessment of Objective response rate (ORR) 2 Years Objective response rate (ORR) assessed by IRC
- Secondary Outcome Measures
Name Time Method Assessment of Time to treatment failure (TTF) 2 Years Assessment of Disease control rate (DCR) 2 Years Assessment of Duration of response (DoR) 2 Years Assessment of Time to progressive disease 2 Years Assessment of Time to response 2 Years Assessment of Progression free survival (PFS) 2 Years Assessment of 1-year progression-free survival 1 Year Assessment of Peak Plasma Concentration (Cmax) or Area under the plasma concentration versus time curve (AUC) 2 Years Assessment of 1-year survival 1 Years Assess incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). 2 Years Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs(SAEs)
Assessment of Overall survival (OS) 2 Years
Trial Locations
- Locations (26)
Linyi Cancer Hospital
π¨π³Linyi, Shangdong, China
OPN Healthcare, Inc.
πΊπΈGlendale, California, United States
University Cancer & Blood Center
πΊπΈAthens, Georgia, United States
Baptist Health
πΊπΈLouisville, Kentucky, United States
University of Maryland Medical Center
πΊπΈBaltimore, Maryland, United States
FirstHealth Cancer Center
πΊπΈPinehurst, North Carolina, United States
The University of Texas- MD Anderson Cancer Center
πΊπΈHouston, Texas, United States
The First Affiliated Hospital of Bengbu Medical College
π¨π³Bengbu, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
π¨π³Beijing, Beijing, China
Beijing Cancer Hospital
π¨π³Beijing, Beijing, China
Peking Union Medical College Hospital
π¨π³Beijing, Beijing, China
Beijing Chest Hospital
π¨π³Beijing, Beijing, China
The Affiliated Cancer Hospital of Chongqin University
π¨π³Chongqing, Chongqing, China
The First Affiliated Hospital of Guangzhou Medical University
π¨π³Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
π¨π³Harbin, Heilongjiang, China
Henan Cancer Hospital
π¨π³Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
Wuhan Union Hospital of China
π¨π³Wuhan, Hubei, China
Hunan Cancer Hospital
π¨π³Changsha, Hunan, China
Jiangsu Province Hospital
π¨π³Nanjing, Jiangsu, China
Jilin Cancer Hospital
π¨π³Changchun, Jilin, China
The First Affiliated Hospital of China Medical University
π¨π³Shengyang, Liaoning, China
Shanghai Chest Hospital
π¨π³Shanghai, Shanghai, China
Shanghai Pulmonary Hospital
π¨π³Shanghai, Shanghai, China
Sichuan Cancer Hospital
π¨π³Chengdu, Sichuan, China
Zhejiang Cancer Hospital
π¨π³Hangzhou, Zhejiang, China