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

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).

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Sutetinib Maleate Capsule

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 uncommon EGFR mutations.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoyang Xia; Phone Number: 805-300-9373; Email: Xiaoyang.xia@teligene.com
• Study Contact Backup: Name: Dawei Zhang; Phone Number: 805-300-1019; Email: david.zhang@teligene.com

Study Locations

• United States
  • California
    • Glendale, California, United States, 91203
      • Withdrawn
      • Oncology Physicians Network Healthcare
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California San Diego Moores Cancer Center
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
  • Georgia
    • Athens, Georgia, United States, 30607
      • Recruiting
      • University Cancer & Blood Center (UCBC) - Athens
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Recruiting
      • Mission Cancer + Blood - Mission Cancer Foundation
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Withdrawn
      • Norton Cancer Institute - Downtown
  • New York
    • New Hyde Park, New York, United States, 11042
      • Active, not recruiting
      • Northwell Health
    • New York, New York, United States, 10016
      • Recruiting
      • Perlmutter Cancer Center - 34th Street
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years old and above, 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; Cohort 2: any EGFR TKIs within 5 half-lives.
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 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
6. 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
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm, Open label; Participants will receive sutetinib maleate capsule taken orally with (preferred) or without food, at the dose directed by the Investigators, 28 days for a cycle.	Drug: Sutetinib Maleate Capsule; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR)	Pre-dose up to approximately 32 months post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
1-year Survival	Ratio of surviving participants 1 year after the first dose of IP.	Pre-dose up to 1 year post-dose
Area Under The Curve (AUC) of Sutetinib Maleate Capsule		Pre-dose up to 24 hours post-dose
Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule		Pre-dose up to 24 hours post-dose
Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule		Pre-dose up to 24 hours post-dose
Time to Peak Drug Concentration (Tmax) of Sutetinib Maleate Capsule		Pre-dose up to 24 hours post-dose
Sutetinib Maleate Capsule half-life (T1/2)		Pre-dose up to 24 hours post-dose
Apparent Clearance (CL/f) of Sutetinib Maleate Capsule		Pre-dose up to 24 hours post-dose
Volume of Distribution (Vz/F) of Sutetinib Maleate Capsule		Pre-dose up to 24 hours post-dose
Duration of Response (DoR)		Pre-dose up to approximately 32 months post-dose
Disease Control Rate (DCR)		Pre-dose up to approximately 32 months post-dose
Progression Free Survival (PFS)		Pre-dose up to approximately 32 months post-dose
Time to Tumor Progression (TTP)		Pre-dose up to approximately 32 months post-dose
Time to Response (TTR)		Pre-dose up to approximately 32 months post-dose
Time to Treatment Failure (TTF)		Pre-dose up to approximately 32 months post-dose
Overall Survival (OS)		Pre-dose up to approximately 32 months post-dose
Number of Participants Experiencing Adverse Events (AE)		Pre-dose up to approximately 32 months post-dose
Number of Participants Experiencing Adverse Drug Reactions (ADR)		Pre-dose up to approximately 32 months post-dose
Number of Participants Experiencing Serious Adverse Events (SAE)		Pre-dose up to approximately 32 months post-dose
Number of Participants Experiencing Srious Adverse Reactions (SAR)		Pre-dose up to approximately 32 months post-dose

Collaborators and Investigators

• Sponsor: Teligene US

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Oncology; Teligene; Sutetinib Maleate Capsule
• Additional Relevant MeSH Terms: Neoplasms by Site; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Maleic acid
• Other Study ID Numbers: TL-EGFR-2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No