drugset / Trial / NCT05284994

TQ-B3525 Tablets Combined With Osimertinib Mesylate Tablets in the Treatment of Advanced Non-Small Cell Lung Cancer

NCT05284994

Phase 1/2 Unknown 160 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

TQ-B3525 tablet is a new α/δ dual inhibitor phosphatidylinositol 3-kinase inhibitor developed by Chia Tai Tianqing pharmaceutical Group Co., Ltd. It can overcome the drug resistance problem caused by the up-regulation of phosphatidylinositol 3-kinase α subunit activity caused by the single inhibition of phosphatidylinositol 3-kinase δ subunit. This study is a single-arm, open-label, multi-cohort, multi-center clinical study of the safety and efficacy of TQ-B3525 tablets combined with osimertinib in subjects with advanced non-small cell lung cancer, aiming to evaluate TQ-B3525 tablets combined with osimertinib, the safety, tolerability, and efficacy of the treatment of patients with advanced non-small cell lung cancer who have failed epidermal growth factor receptor inhibitor therapy, while exploring the efficacy, resistance mechanism, and safety in the dose escalation phase biomarkers.

Timeline

Start
2022-03-11
Primary completion
2024-04
Completion
2024-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Osimertinib Small molecule
Subject TQ-B3525 Small molecule