Status:
TERMINATED
A Clinical Study to Evaluate the Tolerance, Pharmacokinetics and Efficacy of TQ-A3334 Tablets
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 combinat...
Eligibility Criteria
Inclusion
- 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
- 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
- Has thyroid dysfunction that requires drug treatment within 6 months before the first administration
- Has multiple factors affecting oral medication
- Has any severe acute complications before the first administration
- Have participated in other clinical trials within 4 weeks before the first administration
- According to the judgement of the researchers, there are other factors that may lead to the termination of the study
- In addition to the above criteria, the extended research phase must meet the following criteria:
- Pathologically diagnosed as central, hollow lung squamous cell carcinoma, or non-small cell lung cancer with hemoptysis;
- EGFR and ALK are positive untreated with relevant targeted drugs;
- Has received anlotinib hydrochloride capsules.
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06507891
Start Date
July 6 2020
End Date
June 4 2024
Last Update
July 18 2024
Active Locations (1)
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1
Jingling Hospital
Nanjing, Jiangsu, China, 210023