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Non-small Cell Lung CancerPhase 2NCT06010329

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

A Phase 2 study testing Sutetinib Maleate Capsule in people with Non-small Cell Lung Cancer, run by Teligene US at 24 sites in 2 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

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). 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
66 participants
Where
24 sitesin 2 countries
Study dates
27 Dec 2023to 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
  • 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.

Who cannot join

  • 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; Cohort 2: any EGFR TKIs within 5 half-lives.
  • 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 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
  • 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
Show all 9Show fewer
  • Active central nervous system metastases
  • Any active infection which has not been controlled at screening
  • Other exclusion criteria apply for participating in the Study.

Trial locations and contacts

24 sites in 2 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

24 sites in 2 countries

China14 sites, 14 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Beijing Chest Hospital

    Beijing, Beijing Municipality, 101199

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong, 510095

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Recruiting

  • Jinan Central Hospital

    Jinan, Shandong, 250013

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330000

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

    Recruiting

  • Qujing Central Hospital of Yunnan Province

    Qujing, Yunnan, 655000

    Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200123

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Recruiting

Other trials in China

United States10 sites, 6 recruiting

  • University Cancer & Blood Center (UCBC) - Athens

    Athens, Georgia, 30607

    Recruiting

  • Mission Cancer + Blood - Mission Cancer Foundation

    Des Moines, Iowa, 50309

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Alex Spira, M.D., Ph.D.

    Recruiting

  • Oncology Physicians Network Healthcare

    Glendale, California, 91203

    Withdrawn

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093

    Recruiting

  • Norton Cancer Institute - Downtown

    Louisville, Kentucky, 40202

    Withdrawn

  • Northwell Health

    New Hyde Park, New York, 11042

    Active, not recruiting

  • Perlmutter Cancer Center - 34th Street

    New York, New York, 10016

    Terminated

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

Other trials in United States

About this study

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)

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).

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 uncommon EGFR mutations.

Being tested
Sutetinib Maleate Capsule
Keywords
Oncology, Sutetinib Maleate Capsule, Teligene, Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

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

  • Sutetinib Maleate CapsuleDrug

    Oral administration

Study groups in NCT06010329
Study groupRoleWhat they receive
Single arm, Open labelExperimentalParticipants will receive sutetinib maleate capsule taken orally with (preferred) or without food, at the dose directed by the Investigators, 28 days for a cycle.
Receives: Drug: Sutetinib Maleate Capsule

What is being measured

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

  1. Objective Response Rate (ORR)

    Measured: Pre-dose up to approximately 32 months post-dose

Secondary outcomes (20)

  1. Duration of Response (DoR)

    Measured: Pre-dose up to approximately 32 months post-dose

  2. Disease Control Rate (DCR)

    Measured: Pre-dose up to approximately 32 months post-dose

  3. Progression Free Survival (PFS)

    Measured: Pre-dose up to approximately 32 months post-dose

  4. Time to Tumor Progression (TTP)

    Measured: Pre-dose up to approximately 32 months post-dose

  5. Time to Response (TTR)

    Measured: Pre-dose up to approximately 32 months post-dose

  6. Time to Treatment Failure (TTF)

    Measured: Pre-dose up to approximately 32 months post-dose

  7. Overall Survival (OS)

    Measured: Pre-dose up to approximately 32 months post-dose

  8. 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.

    Measured: Pre-dose up to 1 year post-dose

  9. 1-year Survival

    Ratio of surviving participants 1 year after the first dose of IP.

    Measured: Pre-dose up to 1 year post-dose

  10. Area Under The Curve (AUC) of Sutetinib Maleate Capsule

    Measured: Pre-dose up to 24 hours post-dose

  11. Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule

    Measured: Pre-dose up to 24 hours post-dose

  12. Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule

    Measured: Pre-dose up to 24 hours post-dose

  13. Time to Peak Drug Concentration (Tmax) of Sutetinib Maleate Capsule

    Measured: Pre-dose up to 24 hours post-dose

  14. Sutetinib Maleate Capsule half-life (T1/2)

    Measured: Pre-dose up to 24 hours post-dose

  15. Apparent Clearance (CL/f) of Sutetinib Maleate Capsule

    Measured: Pre-dose up to 24 hours post-dose

  16. Volume of Distribution (Vz/F) of Sutetinib Maleate Capsule

    Measured: Pre-dose up to 24 hours post-dose

  17. Number of Participants Experiencing Adverse Events (AE)

    Measured: Pre-dose up to approximately 32 months post-dose

  18. Number of Participants Experiencing Adverse Drug Reactions (ADR)

    Measured: Pre-dose up to approximately 32 months post-dose

  19. Number of Participants Experiencing Serious Adverse Events (SAE)

    Measured: Pre-dose up to approximately 32 months post-dose

  20. Number of Participants Experiencing Srious Adverse Reactions (SAR)

    Measured: Pre-dose up to approximately 32 months post-dose

Timeline

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

  1. First posted24 Aug 2023
  2. Study start27 Dec 2023
  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
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06010329
Sponsor's protocol ID
TL-EGFR-2201
Status last verified
Oct 2026
First submitted
18 Aug 2023
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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 24 sites in 2 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 9 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China, United States. 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?

Objective Response Rate (ORR) (time frame: Pre-dose up to approximately 32 months post-dose). 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 NCT06010329.

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 2 Nov 2026.

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