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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06706713 on ClinicalTrials.gov