Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer
NCT06706713 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2024-11-26
Summary
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
- Non-Small Cell Lung Cancer
- EGFR Exon 20 Insertion Mutation
Interventions
- DRUG
-
BEBT-109 Capsule
Take orally before breakfast and dinner each day, with a minimum interval of 9 hours between doses, 120mg each time, twice a day,and 28 days as a treatment cycle.
Sponsors & Collaborators
-
BeBetter Med Inc
lead INDUSTRY
Principal Investigators
-
Nong Yang, Phd · Hunan Cancer Hospital
-
Yilong Wu, Phd · Guangdong Provincial People's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-15
- Primary Completion
- 2025-12-31
- Completion
- 2026-06-30
Countries
- China
Study Locations
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