Study to Evaluate Sutetinib Maleate Capsule in Locally Advanced or Metastatic Non-small Cell Lung Cancer

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)

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)

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 non-resistant uncommon EGFR mutations

• Study Type: Interventional
• Enrollment (Anticipated): 99
• 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
      • Recruiting
      • OPN Healthcare, Inc.
      • Contact: Heather Lyon; Phone Number: 818-254-2526; Email: heatherl@opnhc.com
      • Principal Investigator: Anthony Lam, MD, MHS
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Not yet recruiting
      • University of Maryland Medical Center
      • Contact: Katherina Scilla, M.D.; Phone Number: 410-328-6373; Email: kschrenk@umm.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas- MD Anderson Cancer Center
      • Contact: Xiuning Le, M.D., Ph.D.; Phone Number: 713-792-6363

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (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 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).

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: Sutetinib Maleate Arm; Sutetinib capsules monotherapy	Drug: Sutetinib Maleate Capsule; Study drug to be taken orally with or without food (with food preferred) for up to13 cycles; Other Names: Sutetinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Objective response rate (ORR)	Objective response rate (ORR) assessed by IRC	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Duration of response (DoR)		2 Years
Assessment of Disease control rate (DCR)		2 Years
Assessment of Progression free survival (PFS)		2 Years
Assessment of Time to progressive disease		2 Years
Assessment of Time to response		2 Years
Assessment of Time to treatment failure (TTF)		2 Years
Assessment of Overall survival (OS)		2 Years
Assessment of 1-year progression-free survival		1 Year
Assessment of 1-year survival		1 Years
Assess incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).	Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs(SAEs)	2 Years
Assessment of Peak Plasma Concentration (Cmax) or Area under the plasma concentration versus time curve (AUC)		2 Years

Collaborators and Investigators

• Sponsor: Teligene US

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: December 12, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: lung cancer; EGFR mutation; Malignant tumor
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Maleic acid
• Other Study ID Numbers: SZCT-2020-06

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