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A Clinical Study to Evaluate the Tolerance, Pharmacokinetics and Efficacy of TQ-A3334 Tablets | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

A Clinical Study to Evaluate the Tolerance, Pharmacokinetics and Efficacy of TQ-A3334 Tablets

A Phase Ib, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance , Pharmacokinetics and Effectiveness of TQ-A3334 Tablets in Patients With Advanced Non-small Cell Lung Cancer

NCT06507891•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), and maximum tolerated dose (MTD) of single and multiple oral doses of TQ-A3334 and observe the efficacy of TQ-A3334 in combination with anlotinib capsules in patients with non-small cell lung cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Understood and signed an informed consent form;
•18 years old and older; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; life expectancy ≥12 weeks;
•Histologically confirmed advanced non-small cell lung cancer;
•Has received at least two systemic chemotherapy regimens which is failure or intolerance；
•At least one measurable lesion（ based on Response evaluation criteria in solid tumors (RECIST) 1.1;
•The main organs function are normally；
•Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization；
•In addition to the above criteria, the extended research phase must meet the following criteria: epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) are negative; or patients with positive test results of EGFR and ALK are resistant or intolerant after receiving the targeted drug treatment.

Exclusion Criteria

•Small cell lung cancer
•Other malignant tumors that have appeared or are presently present within 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer
•Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks
•Expect to use any active vaccine against infectious diseases within 28 days before the first administration or during the study period
•Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage \> 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration
•Active autoimmune diseases that require systemic treatment have occurred within 2 years before the first administration
•Hypersensitivity to TQ-A3334 or its excipient
•Has uncontrollable symptoms of brain metastases, spinal cord compression, cancerous meningitis
•Has unrelieved toxicity reactions ≥ grade 1 due to previous treatment
•Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear
+9 more criteria

Locations (1)

Jingling Hospital

Nanjing, Jiangsu, China

Key Dates

Start Date

July 6, 2020

Primary Completion Date

August 25, 2023

Completion Date

June 4, 2024

Last Updated

July 18, 2024

Enrollment

ACTUAL participants

Conditions

Non Small Cell Lung Cancer

Interventions

TQ-A3334 tablets

DRUG

TQ-A3334 tablets + Anlotinib capsules

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study to Evaluate the Tolerance, Pharmacokinetics and Efficacy of TQ-A3334 Tablets

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)