Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): After considering the company's project situation and strategic development direction, it has been decided to terminate this project. The experiment will be terminated for non safety reasons.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQ-A3334 tablets | Drug | — | UNRESOLVED |
| TQ-A3334 tablets + Anlotinib capsules | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TQ-A3334 tablets
- description
- TQ-A3334 tablets administered orally on day 1, 8, 15 in 21-day cycle.
- interventionNames
- Drug: TQ-A3334 tablets
- type
- EXPERIMENTAL
- label
- TQ-A3334 tablets + Anlotinib capsules
- description
- TQ-A3334 tablets administered orally on day1, 8, 15 in 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
- interventionNames
- Drug: TQ-A3334 tablets + Anlotinib capsules
Primary outcomes (3)
- measure
- Adverse events (AE)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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