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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

NCT05284994•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1 Aged 18 to 75 years old, and gender is not limited.
•2 The eastern cooperative oncology group（ECOG）score is 0 to 1, and the expected survival time is greater than or equal to 12 weeks.
•3 Subjects with histologically or cytologically confirmed non-small cell lung cancer (NSCLC) and stage IIIB-IV (according to the 8th edition of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification).
•4 The enrollment requirements for the dose escalation phase are as follows:
•1. Patients who have failed previous standard therapy, including disease progression or toxicity intolerance, or who are clinically unsuitable or unacceptable, or who refuse to receive standard therapy.
•2. The test report can reflect the presence of epidermal growth factor receptor (EGFR) sensitive mutations when the subjects were enrolled in this trial.
•3. Requirements for meeting the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment failure criteria:
•1. Subjects without T790M mutation after receiving first- or second-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment resistance in the past; or subjects who have previously received third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment resistance.
•2. According to the definition of response evaluation criteria in solid tumors Recist version 1.1 (Recist 1.1) criteria, disease progression occurs after continuous epidermal growth factor receptor- -tyrosine kinase inhibitor treatment for at least 1 month.
•3. No other systemic therapy between discontinuation of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) and initiation of new therapy.
+28 more criteria

Exclusion Criteria

•1 There are contraindications to Osimertinib Mesylate Tablets administration.
•2 Other malignant tumors that have occurred or are currently at the same time within 3 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor.
•3 The subject has received PI3K inhibitor treatment in the past.
•4 Subjects who have received other systemic anti-tumor drugs within 3 weeks before the first dose, or who are still within the in 5 half-life period of the drug.
•5 Received any major surgical treatment within 4 weeks before the first dosage.
•6 Received any previous radiotherapy for curative purposes within 2 weeks before the first drug.
•7 Unrelieved toxic reactions higher than common terminology criteria for adverse events （CTC AE）grade 1 due to any previous treatment, excluding alopecia.
•8 The subjects had active serious viral, or bacterial, or fungal infections within 4 weeks before the first administration.
•9 One of the following conditions of grade II or above occurred within 6 months before the first medication: myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass grafting, cerebrovascular accident, including transient cerebral ischemia attack, as well as deep vein thrombosis or pulmonary embolism.
•10 Current uncontrolled congestive heart failure.
+13 more criteria

Locations (9)

Sun-Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Southern Hospital of Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

The Second People's Hospital of Guangdong Province

Guanzhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

Affiliated Hospital Of Guangdong Medical University

Zhanjiang, Guangdong, China

Key Dates

Start Date

March 11, 2022

Primary Completion Date

April 1, 2024

Completion Date

June 1, 2024

Last Updated

March 17, 2022

Enrollment

160

ESTIMATED participants

Conditions

Nonsmall-cell Lung Cancer

Interventions

TQ-B3525 Tablets, Osimertinib Mesylate Tablets

DRUG

Contacts

Li Zhang, Doctor

CONTACT

13902282893 zhangli6@mail.sysu.edu.cn

Wenfeng Fang, Doctor

CONTACT

15322302066 fangwf@sysucc.org.cn