Clinical trial · Interventional
Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
Apatinib in the Treatment of Advanced Non-squamous Non-small Cell Lung Cancer:a Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present phase III trial, the investigators will further evaluate the efficacy and toxicities of apatinib in the treatment of advanced non-squamous 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 |
|---|---|---|---|
| apatinib | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Apatinib
- description
- 750 mg，po，QD； 28 days every cycle
- interventionNames
- Drug: apatinib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- 24 months
- description
- Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients 18 to 70 years of age 2. Documented pathological evidence of advanced non-squamous non-small cell lung cancer with measurable lesions 3. Failure of epidermal-growth-factor receptor (EGFR) TKIs target treatment and second-line or more regimens of chemotherapy 4. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 1 5. Patients had to have recovered from any toxic effects of therapy 6. Patients with brain/meninges metastasis should keep stable disease for 2 months before randomisation 7. Adequate hematologic and biochemical values were required Exclusion Criteria: 1. Presence of small-cell lung cancer alone or with NSCLC 2. Pregnant or breast-feeding women 3. Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure \> 140 mmHg，diastolic pressure \> 90 mmHg), cardiac ischemia and infarction, ventricular arrhythmias(QT ≥ 440ms) and grade 1 cardiac insufficiency 4. Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction) 5. Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy 6. ≥ CTCAE 2 pneumorrhagia or ≥ CTCAE 3 hemorrhage in other organs within 4 weeks 7. Bone fracture or wounds that was not cured for a long time 8. Arterial thrombus or phlebothrombosis within 6 months and taking anticoagulant agents 9. Mental diseases and psychotropic substances abuse 10. Previous treatment with an experimental agent within 4 weeks 11. Previous treatment with VEGFR、platelet derived growth factor receptor(PDGFR) TKIS 12. Other coexisting malignant disease (apart from basal-cell carcinoma and carcinoma in situ of uterine cervix)
References
Publications (0)
Data not yet available