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Efficacy and Safety of HL-085 Combined With Vemurafenib in BRAF V600E Patients With Non-small Cell Lung Cancer: a Phase II Clinical Study

Non-small-cell Lung Cancer Clinical Trial

Official title:
A Single-arm, Open, Multicenter Phase II Study to Evaluate the Efficacy and Safety of HL-085 Capsules Combined With Vemurafenib in the Treatment of BRAF V600E Mutated Patients With Unresectable Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Clinical Trial Summary

This is a single-arm, open, multicenter phase II clinical study to evaluate the efficacy and safety of HL-085 capsules combined with Vemurafenib in the treatment of BRAF V600E mutated patients with unresectable locally advanced or metastatic NSCLC. Meanwhile, to explore the relationship between pop-PK characteristics, efficacy and safety in the treatment of HL-085 combined with Vemurafenib

Clinical Trial Description

This study was intended to be divided into two study cocohorts. Cohort one was BRAF V600E mutated NSCLC patients who had not received systemic treatment (first-line). Cohort 2 included patients with BRAF V600E mutated NSCLC who had received systemic therapy (second-line and above); There were 30 patients in cohort 1 and 39 in cohort 2, a total of 69 evaluable cases. A sample size of 73 patients with advanced NSCLC with BRAF V600E mutation (32 /41, respectively) was calculated at a 5% shedding rate. All patients in the first/second line and above were eligible for inclusion. The treatment regimen was HL-085 9mg BID+ Vemurafenib 720mg BID oral administration for 21 days per cycle. The primary efficacy endpoint in this study was the ORR assessed by the Independent Review Committee (IRC) according to the RECIST 1.1 Efficacy Evaluation Criteria for solid tumors. Subjects were evaluated for tumor imaging every 6 weeks (±7 days), and for complete response (CR) or partial response (PR) at the first imaging assessment, reconfirmation was performed at ≥4 weeks. Safety will be assessed by vital signs, physical examination, ECOG score, clinical laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, myocardial enzymes), 12-lead electrocardiogram (ECG), echocardiogram (ECHO) examination, and incidence and severity of AE. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05900219
Study type Interventional
Source Shanghai Kechow Pharma, Inc.
Contact Zhimei Zhu, Master
Phone 15201345822
Email zhuzm@kechowpharma.com
Status Not yet recruiting
Phase Phase 2
Start date September 24, 2023
Completion date September 24, 2025
View Details
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