a clinical study to evaluate the tolerance, pharmacokinetics and efficacy of tq-a3334 tablets

Conditions: Non Small Cell Lung Cancer

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 criteria:
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 * 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: 1. pathologically diagnosed as central, hollow lung squamous cell carcinoma, or non-small cell lung cancer with hemoptysis; 2. egfr and alk are positive untreated with relevant targeted drugs; 3. has received anlotinib hydrochloride capsules.