drugset / Trial / NCT05900219

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

NCT05900219

Phase 2 Unknown 75 enrolled Shanghai Kechow Pharma, Inc.
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2023-09-24
Primary completion
2025-09-24
Completion
2025-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Tunlametinib Small molecule 9 mg Oral
Subject Vemurafenib Small molecule 720 mg Oral