RecruitingPhase 2NCT06706713

Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer

An Apen-label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of BEBT-109 in Patients With EGFR Exon 20 Insertion Mutations in Locally Advanced or Metastatic Non-Small Cell Lung Cancer


Sponsor

BeBetter Med Inc

Enrollment

200 participants

Start Date

Apr 15, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called BEBT-109 in people with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific mutation called an EGFR exon 20 insertion — a mutation that many standard EGFR-targeting drugs don't work against. **You may be eligible if...** - You are 18 or older - You have confirmed advanced or metastatic NSCLC with an EGFR exon 20 insertion mutation - You have already received at least one prior chemotherapy regimen and it either stopped working or you couldn't tolerate it - You are in acceptable overall health condition **You may NOT be eligible if...** - You have not yet tried standard chemotherapy - You have other types of EGFR mutations (not exon 20 insertion) - Your overall health would make this treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBEBT-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.


Locations(2)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Hunan Cancer Hospital

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

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NCT06706713


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