MedTrace Logo

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

NCT06514027 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-23

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

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.

Sponsors & Collaborators

  • BeBetter Med Inc

    lead INDUSTRY

Principal Investigators

  • Li Zhang, Master · Sun Yat-sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2027-06-30
Completion
2027-11-30

Countries

  • China

Study Locations

More Related Trials

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 NCT06514027 on ClinicalTrials.gov