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

Recruiting now · Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT06010329

Run by

Teligene US

People needed

66

Starts

2023-12-27

Expected to finish

2028-12-01

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Active central nervous system metastases
• Any active infection which has not been controlled at screening
• Other exclusion criteria apply for participating in the Study.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• University of California San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• University Cancer & Blood Center (UCBC) - Athens — Athens, Georgia, United States (enrolling)
• Mission Cancer + Blood - Mission Cancer Foundation — Des Moines, Iowa, United States (enrolling)
• Perlmutter Cancer Center - 34th Street — New York, New York, United States (enrolling)
• Northwell Health — New Hyde Park, New York, United States
• Oncology Physicians Network Healthcare — Glendale, California, United States
• Norton Cancer Institute - Downtown — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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