NCT06514027

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

A Multicenter, Open Phase II Clinical Study on the Safety and Efficacy of BEBT-109 Combined With Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: BeBetter Med Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of BEBT-109 combined with injectable pemetrexed disodium and carboplatin or cisplatin injection as first-line treatment for locally advanced, recurrent, or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations.

Detailed description

This study initially sets up two cohorts. In cohort 1, the treatment is BEBT-109 combined with investigator-selected chemotherapy (injectable pemetrexed disodium combined with carboplatin or cisplatin injection). In cohort 2, the treatment is BEBT-109 monotherapy (BEBT-109 capsule at a dose of 180mg, taken orally once daily). Based on different dosing regimens of BEBT-109 capsules, cohort 1 is divided into three dose groups: A (BEBT-109 capsule at a dose of 180mg, taken orally once daily), B (BEBT-109 capsule at a dose of 120mg, taken orally twice daily), and C (BEBT-109 capsule at a dose of 120mg, taken orally once daily). Dose group A will first enroll six subjects to receive one cycle (a treatment cycle is 21 days) of drug treatment, and the safety data of subjects in dose group A will determine whether to adjust the dose for cohort 1 or to initiate other dose groups. If ≤2 subjects experience dose-limiting toxicity (DLT) during the DLT observation period, dose group A will be expanded to 20-30 subjects, and the decision to initiate dose group B will be made jointly by the investigators and the sponsor. If more than 2 subjects experience DLT, the decision to continue the study or to initiate dose group C will be made jointly by the investigators and the sponsor. Subjects in dose groups B and C will also initially enroll six subjects to undergo DLT safety follow-up, and then the decision to expand to 20-30 subjects will be made jointly by the investigators and the sponsor. The decision to initiate cohort 2 will be based on the safety and efficacy results from cohort 1. Each subject's study process includes three phases: screening, treatment, and follow-up. During the treatment period, subjects will undergo tumor assessments every 6 weeks ± 7 days. After discontinuing treatment, subjects will enter the follow-up period, where subjects without progressive disease (PD) will receive efficacy follow-up every 6 weeks ± 7 days (until tumor progression, death, or other antitumor treatment is initiated), and survival follow-up every 3 months (± 2 weeks). All subjects will receive study drug treatment until PD, death, intolerable toxicity occurs, or the subject withdraws informed consent (whichever occurs first).

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	BEBT-109 Capsules	BEBT-109 Capsules: Administration and Dosage: Oral administration, 120mg or 180mg; Frequency and Duration of Administration: Once a day or twice a day,and 21 days as a treatment cycle.
DRUG	Pemetrexed Disodium for Injection	Pemetrexed Disodium for Injection: Administration and Dosage: Intravenous infusion, 500mg/m\^2; Frequency and Duration of Administration: On the first day of each cycle,and 21 days as a treatment cycle.
DRUG	Carboplatin Injection	Carboplatin Injection: Administration and Dosage: Intravenous infusion, AUC=5 mg/ml.min, with a single dose not exceeding 800 mg; Frequency and Duration of Administration: On the first day of each cycle for the first four cycles, and 21 days as a treatment cycle, totaling four cycles.
DRUG	Cisplatin Injection	Cisplatin Injection: Administration and Dosage: Intravenous infusion, 75 mg/m\^2; Frequency and Duration of Administration: On the first day of each cycle for the first four cycles, and 21 days as a treatment cycle, totaling four cycles.

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-06-01
• Completion: 2027-11-01
• First posted: 2024-07-23
• Last updated: 2024-07-23

Locations

1 site across 1 country: China