A Clinical Study to Evaluate the Tolerance, Pharmacokinetics and Efficacy of TQ-A3334 Tablets
NCT Number: NCT06507891
Status: TERMINATED
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Non Small Cell Lung Cancer
Interventions: DRUG: TQ-A3334 tablets|DRUG: TQ-A3334 tablets + Anlotinib capsules
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-07-06
Completion Date: 2024-06-04
Locations: Jingling Hospital, Nanjing, Jiangsu, 210023, China

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.

Primary Outcome Measures: Adverse events (AE), The occurrence of adverse events and serious adverse events., Baseline up to 21 days|Dose limited toxicity (DLT), DLT defined as any of the following events occurring during the study related to drugs: (1) ≥grade 3 non-hematologic toxicity; (2) Grade 4 neutropenia, thrombocytopenia, and hemoglobin reduction confirmed by at least 2 tests within 2 days; (3) Grade 3 neutropenia with fever confirmed at least 2 times within 2 days; (4) Immune-related interstitial pneumonia ≥ grade 2; (5) Decreased ventricular ejection fraction ≥ grade 2 ; (6) Retinal vein occlusion (RVO), uveitis ≥ grade 2., Baseline up to 21 days|Maximum tolerable dose (MTD), MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT)., Baseline up to 21 days
Secondary Outcome Measures: Tmax, To characterize the pharmacokinetics of TQ-A3334 by assessment of time to reach maximum plasma concentration., 5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29|Cmax, Cmax is the maximum plasma concentration of TQ-A3334 or metabolite(s)., 5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29|t1/2, t1/2 is time it takes for the blood concentration of TQ-A3334 or metabolite(s) to drop by half., 5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29|Area under the plasma concentration-time curve (AUC 0-t), To characterize the pharmacokinetics of TQ-A3334 by assessment of area under the plasma concentration time curve from zero to infinity., 5 minutes, 15 minutes, 0.5 hour, 45 minutes, 1 hour, 1.5 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 144 hour after oral administration on day 1 and day 29; 30 minutes before oral administration on day 1, day 8, day 15,day 22 and day 29|Overall response rate (ORR), Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)., Up to 96 weeks|Progression-free survival (PFS), PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause., Up to 96 weeks|Duration of Response (DOR), Time from tumor first assessment to CR or PR to first assessment to PD (Progressive Disease) or death from any cause., Up to 96 weeks|Disease control rate (DCR), Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD)., Up to 96 weeks