To hear about similar clinical trials, please enter your email below
Trial Title:
A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC
NCT ID:
NCT06010329
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Maleic acid
Conditions: Keywords:
Oncology
Sutetinib Maleate Capsule
Teligene
Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sutetinib Maleate Capsule
Description:
Oral administration
Arm group label:
Single arm, Open label
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).
Detailed description:
Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a
gene that makes a protein that is involved in cell growth and cell survival. Mutated
(changed) forms of the EGFR gene and protein have been found in some types of cancer,
including non-small cell lung cancer. These changes may cause cancer cells to grow and
spread in the body. The purpose of this study is to explore how effective Sutetinib
maleate capsules are for the treatment of patients with locally advanced or metastatic
NSCLC with uncommon EGFR mutations.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years old, 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
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 Grade 1, at the time of
screening except for 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. Any active infection which has not been controlled at screening.
Other exclusion criteria apply for participating in the Study
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Oncology Physicians Network Healthcare
Address:
City:
Glendale
Zip:
91203
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California San Diego Moores Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
University Cancer & Blood Center (UCBC) - Athens
Address:
City:
Athens
Zip:
30607
Country:
United States
Status:
Recruiting
Facility:
Name:
Mission Cancer + Blood - Mission Cancer Foundation
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Facility:
Name:
Norton Cancer Institute - Downtown
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Withdrawn
Facility:
Name:
Northwell Health
Address:
City:
New Hyde Park
Zip:
11042
Country:
United States
Status:
Recruiting
Facility:
Name:
Perlmutter Cancer Center - 34th Street
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Start date:
December 27, 2023
Completion date:
September 2025
Lead sponsor:
Agency:
Teligene US
Agency class:
Industry
Source:
Teligene US
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06010329
