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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT05284994
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Nonsmall-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 11, 2022
Status verified
Mar 2022
Primary completion
Apr 30, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
160 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: TQ-B3525 Tablets + Osimertinib Mesylate Tablets.
    TQ-B3525 tablets combined with osimertinib mesylate tablets, 30 days as a treatment cycle.

Primary Outcome Measure

Dose limiting toxicity (DLT) [ Time Frame: Baseline time to increase chemotherapy drug dose to toxicity intolerance, up to 5 weeks. ]

Central Contacts