NCT05284994

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

A Single-arm, Open-label, Multi-cohort, Multi-center Clinical Study on the Safety and Efficacy of TQ-B3525 Tablets Combined With Osimertinib in Subjects With Advanced Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonsmall-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	TQ-B3525 Tablets, Osimertinib Mesylate Tablets	TQ-B3525 is a novel α/δ dual inhibitor PI3K kinase inhibitor. Osimertinib mesylate is a third-generation epidermal growth factor receptor inhibitor.

Timeline

• Start date: 2022-03-11
• Primary completion: 2024-04-01
• Completion: 2024-06-01
• First posted: 2022-03-17
• Last updated: 2022-03-17

Locations

9 sites across 1 country: China