A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or M… (NCT06010329) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC
United States66 participantsStarted 2023-12-27
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: Pre-dose up to approximately 32 months post-dose
. 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