Clinical trial NCT05168566: Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Malignant tumor
EGFR mutation
lung cancer
Lead sponsor: Teligene US
Sponsor class: INDUSTRY
First posted: 2021-12-23
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Age 18 years old and above, male or female.
2. Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC patients with ≤ 1 prior line of chemotherapy.
3. 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..
4. At least one measurable lesion.
5. ECOG score of 0, 1, or 2.
6. A minimum life expectancy of \> 3 months.
7. Adequate bone marrow reserve, hepatic, renal and coagulation function.
8. Willingness of all subjects of childbearing potential to use acceptable methods of birth control.

Exclusion Criteria:

1. Ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for anti-tumor therapy prior to enrollment.
2. 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.
3. 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.
4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment.
5. Any unresolved toxicities from prior therapy greater than Grade 1 at the time of screening except alopecia.
6. Inability to swallow the study medication, any seriously chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption.
7. Active central nervous system metastases
8. 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.
9. Any active infection which has not been controlled at screening.
10. Any serious cardiovascular disease.
11. History of other serious systemic disease not suitable for clinical trial.
12. 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).
13. Known alcohol or drug dependence.
14. Mental disorders or poor compliance.
15. Previously received solid organ transplantation or hematopoietic stem cell transplantation.
16. Females who are pregnant or breastfeeding.
17. Known hypersensitivity to the active ingredients or excipients of the investigational product.
18. Have any other primary malignant tumors within 3 years (except some low- risk cancers).

Primary outcomes:
measure: Assessment of Objective response rate (ORR)
timeFrame: 2 Years
Secondary outcomes:
measure: Assessment of Duration of response (DoR)
timeFrame: 2 Years
measure: Assessment of Disease control rate (DCR)
timeFrame: 2 Years
measure: Assessment of Progression free survival (PFS)
timeFrame: 2 Years
measure: Assessment of Time to progressive disease
timeFrame: 2 Years
measure: Assessment of Time to response
timeFrame: 2 Years
measure: Assessment of Time to treatment failure (TTF)
timeFrame: 2 Years
measure: Assessment of Overall survival (OS)
timeFrame: 2 Years
measure: Assessment of 1-year progression-free survival
timeFrame: 1 Year
measure: Assessment of 1-year survival
timeFrame: 1 Years
measure: Assess incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
timeFrame: 2 Years
measure: Assessment of Peak Plasma Concentration (Cmax) or Area under the plasma concentration versus time curve (AUC)
timeFrame: 2 Years
Other outcomes:
Locations:
city: Glendale
country: United States
facility: OPN Healthcare, Inc.
state: California
city: Athens
country: United States
facility: University Cancer & Blood Center
state: Georgia
city: Louisville
country: United States
facility: Baptist Health
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Pinehurst
country: United States
facility: FirstHealth Cancer Center
state: North Carolina
city: Houston
country: United States
facility: The University of Texas- MD Anderson Cancer Center
state: Texas
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chest Hospital
state: Beijing
city: Chongqing
country: China
facility: The Affiliated Cancer Hospital of Chongqin University
state: Chongqing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital of China
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shengyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shangdong
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: