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

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sutetinib Maleate Capsule
Sponsored by
Teligene US
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Oncology, Sutetinib Maleate Capsule, Teligene, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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 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 Grade 1, at the time of screening except for 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 Any active infection which has not been controlled at screening. Other exclusion criteria apply for participating in the Study

Sites / Locations

  • Oncology Physicians Network HealthcareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm, Open label

Arm Description

Participants will receive sutetinib maleate capsule taken orally with (preferred) or without food, 80 mg once daily, 28 days for a cycle.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Secondary Outcome Measures

Duration of Response (DoR)
Disease Control Rate (DCR)
Progression Free Survival (PFS)
Time to Tumor Progression (TTP)
Time to Response (TTR)
Time to Treatment Failure (TTF)
Overall Survival (OS)
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.
1-year Survival
Ratio of surviving participants 1 year after the first dose of IP.
Area Under The Curve (AUC) of Sutetinib Maleate Capsule
Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule
Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule
Time to Peak Drug Concentration (Tmax) of Sutetinib Maleate Capsule
Sutetinib Maleate Capsule half-life (T1/2)
Apparent Clearance (CL/f) of Sutetinib Maleate Capsule
Volume of Distribution (Vz/F) of Sutetinib Maleate Capsule
Number of Participants Experiencing Adverse Events (AE)
Number of Participants Experiencing Adverse Drug Reactions (ADR)
Number of Participants Experiencing Serious Adverse Events (SAE)
Number of Participants Experiencing Srious Adverse Reactions (SAR)

Full Information

First Posted
August 18, 2023
Last Updated
October 17, 2023
Sponsor
Teligene US
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1. Study Identification

Unique Protocol Identification Number
NCT06010329
Brief Title
A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 25, 2025 (Anticipated)
Study Completion Date
May 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teligene US

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Oncology, Sutetinib Maleate Capsule, Teligene, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm, Open label
Arm Type
Experimental
Arm Description
Participants will receive sutetinib maleate capsule taken orally with (preferred) or without food, 80 mg once daily, 28 days for a cycle.
Intervention Type
Drug
Intervention Name(s)
Sutetinib Maleate Capsule
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
Pre-dose up to approximately 20 months post-dose
Secondary Outcome Measure Information:
Title
Duration of Response (DoR)
Time Frame
Pre-dose up to approximately 20 months post-dose
Title
Disease Control Rate (DCR)
Time Frame
Pre-dose up to approximately 20 months post-dose
Title
Progression Free Survival (PFS)
Time Frame
Pre-dose up to approximately 20 months post-dose
Title
Time to Tumor Progression (TTP)
Time Frame
Pre-dose up to approximately 20 months post-dose
Title
Time to Response (TTR)
Time Frame
Pre-dose up to approximately 20 months post-dose
Title
Time to Treatment Failure (TTF)
Time Frame
Pre-dose up to approximately 20 months post-dose
Title
Overall Survival (OS)
Time Frame
Pre-dose up to approximately 20 months post-dose
Title
1-year Progression Free Survival
Description
Ratio of participants who do not have objective tumor progression or have not died 1 year after the first dose of IP.
Time Frame
Pre-dose up to 1 year post-dose
Title
1-year Survival
Description
Ratio of surviving participants 1 year after the first dose of IP.
Time Frame
Pre-dose up to 1 year post-dose
Title
Area Under The Curve (AUC) of Sutetinib Maleate Capsule
Time Frame
Pre-dose up to 24 hours post-dose
Title
Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule
Time Frame
Pre-dose up to 24 hours post-dose
Title
Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule
Time Frame
Pre-dose up to 24 hours post-dose
Title
Time to Peak Drug Concentration (Tmax) of Sutetinib Maleate Capsule
Time Frame
Pre-dose up to 24 hours post-dose
Title
Sutetinib Maleate Capsule half-life (T1/2)
Time Frame
Pre-dose up to 24 hours post-dose
Title
Apparent Clearance (CL/f) of Sutetinib Maleate Capsule
Time Frame
Pre-dose up to 24 hours post-dose
Title
Volume of Distribution (Vz/F) of Sutetinib Maleate Capsule
Time Frame
Pre-dose up to 24 hours post-dose
Title
Number of Participants Experiencing Adverse Events (AE)
Time Frame
Pre-dose up to approximately 20 months post-dose
Title
Number of Participants Experiencing Adverse Drug Reactions (ADR)
Time Frame
Pre-dose up to approximately 20 months post-dose
Title
Number of Participants Experiencing Serious Adverse Events (SAE)
Time Frame
Pre-dose up to approximately 20 months post-dose
Title
Number of Participants Experiencing Srious Adverse Reactions (SAR)
Time Frame
Pre-dose up to approximately 20 months post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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 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 Grade 1, at the time of screening except for 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 Any active infection which has not been controlled at screening. Other exclusion criteria apply for participating in the Study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyang Xia
Phone
805-300-9373
Email
Xiaoyang.xia@teligene.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dawei Zhang
Phone
805-300-1019
Email
david.zhang@teligene.com
Facility Information:
Facility Name
Oncology Physicians Network Healthcare
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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