A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06010329
• Other study ID #: TL-EGFR-2201
• Status: Recruiting
• Phase: Phase 2
• Start date: December 27, 2023
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Teligene US
• Contact: Xiaoyang Xia
• Phone: 805-300-9373
• Email: Xiaoyang.xia[@]teligene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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 uncommon EGFR mutations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18-75 years old, male or female

2. Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC

3. Confirmation that the tumor harbors an uncommon epidermal growth factor receptor (EGFR) mutation (tumor tissue biopsy)

4. At least one measurable lesion

5. Eastern Cooperative Oncology Group (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 Other inclusion criteria apply for participating in the study

Exclusion Criteria:

1. 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)

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

3. 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

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 for 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. Any active infection which has not been controlled at screening. Other exclusion criteria apply for participating in the Study

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• Sutetinib Maleate Capsule
Oral administration

Locations

Country	Name	City	State
United States	University Cancer & Blood Center (UCBC) - Athens	Athens	Georgia
United States	Oncology Physicians Network Healthcare	Glendale	California
United States	Norton Cancer Institute - Downtown	Louisville	Kentucky
United States	Northwell Health	New Hyde Park	New York
United States	Perlmutter Cancer Center - 34th Street	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Teligene US

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)		Pre-dose up to approximately 20 months post-dose
Secondary	Duration of Response (DoR)		Pre-dose up to approximately 20 months post-dose
Secondary	Disease Control Rate (DCR)		Pre-dose up to approximately 20 months post-dose
Secondary	Progression Free Survival (PFS)		Pre-dose up to approximately 20 months post-dose
Secondary	Time to Tumor Progression (TTP)		Pre-dose up to approximately 20 months post-dose
Secondary	Time to Response (TTR)		Pre-dose up to approximately 20 months post-dose
Secondary	Time to Treatment Failure (TTF)		Pre-dose up to approximately 20 months post-dose
Secondary	Overall Survival (OS)		Pre-dose up to approximately 20 months post-dose
Secondary	1-year Progression Free Survival	Ratio of participants who do not have objective tumor progression or have not died 1 year after the first dose of IP.	Pre-dose up to 1 year post-dose
Secondary	1-year Survival	Ratio of surviving participants 1 year after the first dose of IP.	Pre-dose up to 1 year post-dose
Secondary	Area Under The Curve (AUC) of Sutetinib Maleate Capsule		Pre-dose up to 24 hours post-dose
Secondary	Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule		Pre-dose up to 24 hours post-dose
Secondary	Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule		Pre-dose up to 24 hours post-dose
Secondary	Time to Peak Drug Concentration (Tmax) of Sutetinib Maleate Capsule		Pre-dose up to 24 hours post-dose
Secondary	Sutetinib Maleate Capsule half-life (T1/2)		Pre-dose up to 24 hours post-dose
Secondary	Apparent Clearance (CL/f) of Sutetinib Maleate Capsule		Pre-dose up to 24 hours post-dose
Secondary	Volume of Distribution (Vz/F) of Sutetinib Maleate Capsule		Pre-dose up to 24 hours post-dose
Secondary	Number of Participants Experiencing Adverse Events (AE)		Pre-dose up to approximately 20 months post-dose
Secondary	Number of Participants Experiencing Adverse Drug Reactions (ADR)		Pre-dose up to approximately 20 months post-dose
Secondary	Number of Participants Experiencing Serious Adverse Events (SAE)		Pre-dose up to approximately 20 months post-dose
Secondary	Number of Participants Experiencing Srious Adverse Reactions (SAR)		Pre-dose up to approximately 20 months post-dose