RecruitingPhase 2NCT05168566
Official study title

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

Study 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)

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSutetinib Maleate Capsule

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 27, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?31 U.S. locations

Locations may change over time.

Who runs it?Teligene US

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Teligene US
Interventions being studied
Drug: Sutetinib Maleate Capsule
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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, 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. 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).

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • OPN Healthcare, Inc.Glendale, California
  • Georgetown Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia
  • University Cancer & Blood CenterAthens, Georgia
  • Baptist HealthLouisville, Kentucky
  • University of Maryland Medical CenterBaltimore, Maryland
  • FirstHealth Cancer CenterPinehurst, North Carolina
  • University of Texas MD Anderson Cancer CenterHouston, Texas
  • Virginia Cancer SpecialistsFairfax, Virginia
  • Macquarie University HospitalSydney, New South Wales
  • Sunshine Coast Hospital and Health ServiceBirtinya, Queensland
  • St John of God Subiaco HospitalSubiaco, Western Australia
  • The First Affiliated Hospital of Bengbu Medical CollegeBengbu, Anhui

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 27, 2026. Always confirm current availability with the study team.

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