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

ConditionsNon-Small Cell Lung Cancer EGFR Exon 20 Insertion Mutation

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorBeBetter Med Inc

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects who have been fully informed and are willing to sign the informed consent form.

Age of at least 18 years, with no gender restrictions.

According to the 8th edition of the American Joint Committee on Cancer (AJCC) lung cancer Tumor Node Metastasis (TNM) staging criteria: histologically or cytologically confirmed locally advanced (stages IIIB or IIIC, and deemed unsuitable for surgery or radiotherapy by the investigator) or metastatic (stage IV) NSCLC.

Written test reports confirm the occurrence of EGFR exon 20 insertion mutations.

Disqualifiers

Individuals who have had other malignant tumors within 5 years prior to enrollment, except for basal cell carcinoma of the skin that has been removed and cured, in situ bladder cancer, or in situ cervical cancer.

Those who have previously received drugs for EGFR exon 20 insertion mutations, such as Poziotinib, Tarloxotinib, TAK788, JNJ-61186372, CLN-081, or high-dose third-generation EGFR TKIs (Osimertinib > 80 mg/day, Furmonertinib > 80 mg/day, or Almonertinib > 110 mg/day, etc.).

Any other anti-cancer treatment within 4 weeks prior to the first use of the study drug (including cytotoxic chemotherapy, radiotherapy, immunotherapy, or other biological therapies; for Mitomycin or Nitrosoureas, within 6 weeks; for small molecule targeted drugs, at least 2 weeks or at least 5 half-lives from the last dose, whichever is longer).

Received medication from another clinical trial within 4 weeks prior to the first administration of the study treatment.

Trial design

Design model

Single group

Treatments tested in this trial

BEBT-109 Capsule
Drug
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.

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: BEBT-109 Capsule TreatmentExperimental treatment 1 intervention

Trial outcomes