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Non-small Cell Lung CancerPhase 2NCT05168566

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

A Phase 2 study testing Sutetinib Maleate Capsule in people with Non-small Cell Lung Cancer, run by Teligene US at 31 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Sutetinib Maleate Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
31 sitesin 3 countries
Study dates
1 Sep 2022to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years old and above, male or female.
  • Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC patients with ≤ 1 prior line of chemotherapy.
  • 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..
  • At least one measurable lesion.
  • ECOG score of 0, 1, or 2.
  • A minimum life expectancy of > 3 months.
  • Adequate bone marrow reserve, hepatic, renal and coagulation function.
  • Willingness of all subjects of childbearing potential to use acceptable methods of birth control.

Who cannot join

  • Ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for anti-tumor therapy prior to enrollment.
  • 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 (including Chinese patent medicine) within 2 weeks prior to enrollment.
  • 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.
  • 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 alopecia.
  • Inability to swallow the study medication, any seriously chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption.
Show all 18Show fewer
  • Active central nervous system metastases
  • 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.
  • Any active infection which has not been controlled at screening.
  • Any serious cardiovascular disease.
  • History of other serious systemic disease not suitable for clinical trial.
  • 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).
  • Known alcohol or drug dependence.
  • Mental disorders or poor compliance.
  • Previously received solid organ transplantation or hematopoietic stem cell transplantation.
  • Females who are pregnant or breastfeeding.
  • Known hypersensitivity to the active ingredients or excipients of the investigational product.
  • Have any other primary malignant tumors within 3 years (except some low- risk cancers).

Trial locations and contacts

31 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Xiaoyang Xia contact

805-300-9373

Xiaoyang.xia@teligene.com

Dawei Zhang contact

805-300-1019

david.zhang@teligene.com

31 sites in 3 countries

China20 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Active, not recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Active, not recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Active, not recruiting

  • Beijing Chest Hospital

    Beijing, Beijing Municipality, 101125

    Active, not recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 230000

    Active, not recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

    Active, not recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410006

    Active, not recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610044

    Active, not recruiting

  • The Affiliated Cancer Hospital of Chongqing University

    Chongqing, Chongqing Municipality, 400044

    Active, not recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510230

    Active, not recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Active, not recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150086

    Active, not recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong, 276001

    Active, not recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Active, not recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200052

    Active, not recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200437

    Active, not recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Active, not recruiting

  • Wuhan Union Hospital of China

    Wuhan, Hubei, 430000

    Active, not recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Active, not recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Active, not recruiting

Other trials in China

United States8 sites, 6 recruiting

  • University Cancer & Blood Center

    Athens, Georgia, 30607

    Petros Nikolinakos, MD

    Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

    Samuel Rosner, M.D., 410-328-6373, samuel.rosner@som.umaryland.edu

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Alexander Spira, M.D., Ph.D.

    Recruiting

  • OPN Healthcare, Inc.

    Glendale, California, 91203

    Heather Lyon, 818-254-2526, heatherL@opnhc.com

    Anthony Lam, MD, MHS

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Active, not recruiting

  • Baptist Health

    Louisville, Kentucky, 40223

    Withdrawn

  • FirstHealth Cancer Center

    Pinehurst, North Carolina, 28374

    Charles Kuzma, MD

    Recruiting

  • Georgetown Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

    Joshua E Reuss, MD

    Recruiting

Other trials in United States

Australia3 sites, 3 recruiting

  • Sunshine Coast Hospital and Health Service

    Birtinya, Queensland, 4575

    Cassie Turner, MD

    Recruiting

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

    Timothy Clay, MD

    Recruiting

  • Macquarie University Hospital

    Sydney, New South Wales, 2109

    John Park, MD

    Recruiting

Other trials in Australia

About this study

Official title: 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)

Read the 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

Being tested
Sutetinib Maleate Capsule
Keywords
Malignant tumor, EGFR mutation, lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sutetinib Maleate CapsuleDrug

    Also called Sutetinib

    Study drug to be taken orally once daily

Study groups in NCT05168566
Study groupRoleWhat they receive
Sutetinib Maleate ArmExperimentalSutetinib capsules monotherapy
Receives: Drug: Sutetinib Maleate Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of Objective response rate (ORR)

    Objective response rate (ORR) assessed by IRC

    Measured: 2 Years

Secondary outcomes (11)

  1. Assessment of Duration of response (DoR)

    Measured: 2 Years

  2. Assessment of Disease control rate (DCR)

    Measured: 2 Years

  3. Assessment of Progression free survival (PFS)

    Measured: 2 Years

  4. Assessment of Time to progressive disease

    Measured: 2 Years

  5. Assessment of Time to response

    Measured: 2 Years

  6. Assessment of Time to treatment failure (TTF)

    Measured: 2 Years

  7. Assessment of Overall survival (OS)

    Measured: 2 Years

  8. Assessment of 1-year progression-free survival

    Measured: 1 Year

  9. Assessment of 1-year survival

    Measured: 1 Years

  10. 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)

    Measured: 2 Years

  11. Assessment of Peak Plasma Concentration (Cmax) or Area under the plasma concentration versus time curve (AUC)

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2021
  2. Study start1 Sep 2022
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05168566
Sponsor's protocol ID
SZCT-2020-06
Status last verified
Oct 2026
First submitted
12 Dec 2021
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wu F, Zhang W, Zhao Y, Yu Y, Fang J, Han S, Zhao M, Yao W, Wei Y, Shi J, Chen J, Li X, Hong W, Meng R, Shu Y, Zhou C, Zhou Z, Hu Y, Duan J, Yu H, Wang M, Nikolinakos PG, Le X, Han B, Zhou C. Sutetinib for Patients with Non-Small Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Multicenter, Open-Label, Phase IIb Trial. J Thorac Oncol. 2026 Aug 24:104165. doi: 10.1016/j.jtho.2026.104165. Online ahead of print.

    PubMed 42637134

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sutetinib Maleate Capsule in people with Non-small Cell Lung Cancer, run by Teligene US at 31 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaoyang Xia (805-300-9373, Xiaoyang.xia@teligene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Objective response rate (ORR) (time frame: 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05168566, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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