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

April 22, 2026 updated by: Teligene US

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 230000
        • Active, not recruiting
        • the First Affiliated Hospital of Bengbu Medical College
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Active, not recruiting
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China, 100021
        • Active, not recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
      • Beijing, Beijing Municipality, China, 100730
        • Active, not recruiting
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, China, 101125
        • Active, not recruiting
        • Beijing Chest Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400044
        • Active, not recruiting
        • The Affiliated Cancer Hospital of Chongqin University
    • Guangdong
      • Guangzhou, Guangdong, China, 510230
        • Active, not recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
        • Active, not recruiting
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Active, not recruiting
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China, 450052
        • Active, not recruiting
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Active, not recruiting
        • Wuhan Union Hospital of China
    • Hunan
      • Changsha, Hunan, China, 410006
        • Active, not recruiting
        • Hunan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Active, not recruiting
        • Jiangsu Province Hospital
    • Jilin
      • Changchun, Jilin, China, 130012
        • Active, not recruiting
        • Jilin cancer hospital
    • Liaoning
      • Shengyang, Liaoning, China, 830000
        • Active, not recruiting
        • The First Affiliated Hospital of China Medical University
    • Shangdong
      • Linyi, Shangdong, China, 276001
        • Active, not recruiting
        • Linyi Cancer Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200052
        • Active, not recruiting
        • Shanghai Chest Hospital
      • Shanghai, Shanghai Municipality, China, 200437
        • Active, not recruiting
        • Shanghai Pulmonary Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610044
        • Active, not recruiting
        • Sichuan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Active, not recruiting
        • Zhejiang Cancer Hospital
  • United States
    • California
      • Glendale, California, United States, 91203
        • Recruiting
        • OPN Healthcare, Inc.
        • Contact:
        • Principal Investigator:
          • Anthony Lam, MD, MHS
    • Georgia
      • Athens, Georgia, United States, 30607
        • Recruiting
        • University Cancer & Blood Center
        • Contact:
          • Petros Nikolinakos, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40223
        • Withdrawn
        • Baptist Health
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • FirstHealth Cancer Center
        • Contact:
          • Charles Kuzma, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Active, not recruiting
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of Objective response rate (ORR)
Time Frame: 2 Years
Objective response rate (ORR) assessed by IRC
2 Years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of Duration of response (DoR)
Time Frame: 2 Years
2 Years
Assessment of Disease control rate (DCR)
Time Frame: 2 Years
2 Years
Assessment of Progression free survival (PFS)
Time Frame: 2 Years
2 Years
Assessment of Time to progressive disease
Time Frame: 2 Years
2 Years
Assessment of Time to response
Time Frame: 2 Years
2 Years
Assessment of Time to treatment failure (TTF)
Time Frame: 2 Years
2 Years
Assessment of Overall survival (OS)
Time Frame: 2 Years
2 Years
Assessment of 1-year progression-free survival
Time Frame: 1 Year
1 Year
Assessment of 1-year survival
Time Frame: 1 Years
1 Years
Assess incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time Frame: 2 Years
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)
Time Frame: 2 Years
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teligene US

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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