Evaluating Sutetinib for Advanced Non-Small Cell 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 study aims to assess the efficacy and safety of sutetinib maleate capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that have uncommon EGFR mutations. Sutetinib is an investigational drug that works as an irreversible EGFR tyrosine kinase inhibitor, targeting mutated forms of the EGFR gene that contribute to cancer growth. Participants will be monitored for treatment response and safety outcomes, with eligibility criteria focusing on specific tumor characteristics and patient health status.

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
3. Confirmation that the tumor harbors an uncommon epidermal growth factor receptor (EGFR) mutation (tumor tissue biopsy)
4. At least one measurable lesion
5. Eastern Cooperative Oncology Group (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

Other inclusion criteria apply for participating in the study.

Exclusion Criteria:

1. 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)
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.
3. 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
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 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
6. 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
7. Active central nervous system metastases
8. Any active infection which has not been controlled at screening

Other exclusion criteria apply for participating in the Study.

Where it's running

• University of California San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• University Cancer & Blood Center (UCBC) - Athens
  Athens, Georgia, United States Recruiting
• Mission Cancer + Blood - Mission Cancer Foundation
  Des Moines, Iowa, United States Recruiting
• University of Texas MD Anderson Cancer Center
  Houston, Texas, 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.

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

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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.