Actively Recruiting
Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer
Led by BeBetter Med Inc · Updated on 2024-11-26
200
Participants Needed
2
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, multicenter Phase II trial, planning to enroll 200 subjects, using BEBT-109 capsules as monotherapy, aimed at evaluating the efficacy and safety of BEBT-109 capsules in subjects with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations in locally advanced or metastatic Non-Small Cell Lung Cancer （NSCLC）.
CONDITIONS
Official Title
Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- At least 18 years old
- Confirmed locally advanced (stage IIIB or IIIC) or metastatic (stage IV) NSCLC not suitable for surgery or radiotherapy
- Confirmed EGFR exon 20 insertion mutation by test report
- Cohort 1: Failed or intolerant to at least one systemic chemotherapy and no prior third-generation EGFR TKI treatment
- Cohort 2: Failed or intolerant to at least one systemic chemotherapy and progressed after standard-dose third-generation EGFR TKI treatment
- ECOG performance status 0-2 with no decline in past 2 weeks and expected survival of at least 12 weeks
- At least one measurable lesion by RECIST 1.1 criteria
- Adequate organ function shown by laboratory tests
- Women with childbearing potential must use effective contraception and have a negative pregnancy test
- Male subjects must agree to use barrier contraception during the study
You will not qualify if you...
- Other malignant tumors within 5 years except treated basal cell carcinoma, in situ bladder or cervical cancer
- Prior treatment with drugs targeting EGFR exon 20 insertion mutations or high-dose third-generation EGFR TKIs
- Any anti-cancer treatment within 4 weeks before starting study drug (longer for some treatments)
- Participation in another clinical trial within 4 weeks before study drug
- Major surgery within 4 weeks before study drug
- Use of strong CYP3A4 or CYP2C8 inhibitors or inducers within 1 week before study drug
- Unresolved toxicities greater than Grade 1 from previous treatments except alopecia and certain neurotoxicities
- Spinal cord compression, meningeal metastasis, or unstable brain metastases
- Symptomatic and unstable pleural effusion or ascites
- Severe or uncontrolled systemic diseases such as hypertension, diabetes, heart failure, recent myocardial infarction, or active bleeding
- Uncontrolled active infections including active Hepatitis B or C
- History of immunodeficiency or organ transplantation
- Prolonged QT interval or serious cardiac rhythm abnormalities
- Conditions increasing risk of arrhythmias
- History of interstitial lung disease or radiation pneumonitis requiring steroids
- Gastrointestinal issues affecting drug absorption
- Hypersensitivity to BEBT-109 components
- Breastfeeding females
- Any other clinical or laboratory abnormalities making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
2
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
K
Kegang Jiang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here