Clinical trial · Interventional
Study of Apatinib as 3rd/4th Line Treatment in Patients With Advanced Non-Squamous Non-small Cell Lung Cancer Harboring Wild-type Epidermal Growth Factor Receptor (EGFR)
A Randomized, Double-blind, Placebo-controlled, Phase III Trial of Apatinib as 3rd/4th Line Treatment in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer Harboring Wild-type Epidermal Growth Factor Receptor (EGFR)
- 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 selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI). The investigators have finished the preclinical,phase I and phase II clinical studies and found its promising anti-tumor activity and tolerable toxicities. A disease-control rate of 61.1% and a mPFS of 4.7 months were showed in apatinib phase II study in patients with NSCLC. The study aims to compare the efficacy and safety of apatinib to placebo in advanced non-squamous non-small cell lung cancer patients.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | 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
- Apatinib tablet administered orally, 750 mg,once daily until progression
- interventionNames
- Drug: Apatinib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo tablet administered orally, once a day until progression
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Overall Survival(OS)
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects \>/= 18 years and \</=70 years of age at the time of Informed Consent. 2. Advanced relapsed or refractory predominantly NSCLC with documented wild-type EGFR. 3. At least one measurable lesion according to RECIST 1.1. 4. Failure of second line of chemotherapy. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 6. Patients must have recovered from any AEs of prior treatments before randamization. 7. Adequate bone marrow,liver and renal function as assessed by the following laboratory tests conducted within 1 week before randomization. HB ≥ 90g/L; ANC≥1.5×10E+9/L; PLT≥80×10E+9/L; ALT and AST \< 2.5×ULN; TBIL ≤1.25×ULN; Cr ≤1.25×ULN;CL\>45 ml/min. 8. Life expectancy of at least three months. 9. Written informed consent and the willingness and ability to comply with all aspects of the protocol. Exclusion Criteria: 1. Presence of types of small-cell, squamous-cell, adeno-squamous-cell lung cancer. 2. Pregnant or breast-feeding women. 3. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female≥ 470 ms).Severe or uncontrolled systemic disease such as clinically significant hypertension(systolic pressure \>/= 140 mm Hg and/or diastolic pressure \>/= 90 mm Hg), and Grade III-IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF\<50%. 4. Factors to affect oral administration(inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction). 5. Coagulation disfunction,hemorrhagic tendency or receiving anticoagulant therapy\>/= CTCAE 2 pneumorrhagia or \>/= CTCAE 3 hemorrhage in other organs within 4 weeks. 6. Bone fracture or wounds that was not cured. 7. Arterial thrombus or phlebothrombosis within 12 months and taking anticoagulant agents. 8. Mental diseases and psychotropic substances abuse. 9. Previous treatment with an trial agent within 4 weeks 10. Previous treatment with VEGFR,platelet derived growth factor receptor(PDGFR) TKIs. 11. Proteinuria ≥ (++) or 24 hours total urine protein \> 1.0 g. 12. Other coexisting malignant disease (except basal-cell carcinoma and carcinoma in situ of uterine cervix).
References
Publications (0)
Data not yet available