Evaluating Sutetinib for Advanced Lung Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2b multicenter, open-label study aims to assess the safety and efficacy of Sutetinib Maleate Capsule in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring specific non-resistant uncommon EGFR mutations. The study will involve patients who have had limited prior chemotherapy and will evaluate the drug's effectiveness in inhibiting cancer cell growth associated with these mutations. Participants will receive Sutetinib and be monitored for treatment outcomes and side effects.

Why it matters

Who can join: the full rules

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, 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).

Where it's running

• OPN Healthcare, Inc.
  Glendale, California, United States Recruiting
• Georgetown Lombardi Comprehensive Cancer Center
  Washington D.C., District of Columbia, United States Recruiting
• University Cancer & Blood Center
  Athens, Georgia, United States Recruiting
• University of Maryland Medical Center
  Baltimore, Maryland, United States Recruiting
• FirstHealth Cancer Center
  Pinehurst, North Carolina, United States Recruiting
• Virginia Cancer Specialists
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Xiaoyang Xia
• Email: Xiaoyang.xia@teligene.com
• Phone: 805-300-9373

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating Sutetinib for Advanced Non-Small Cell Lung Cancer

  This study is testing a new drug called sutetinib to see if it can help people with advanced lung cancer that has specific gene mutations.

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• SI-B036 safety test in advanced and metastatic solid tumors

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• Postoperative EGFR-TKI Therapy for EGFR-mutant NSCLC Following Surgery

  This registry tests whether giving an EGFR-TKI after surgery helps adults with EGFR-mutant, high-risk early-stage NSCLC.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07837739

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.