Clinical trial · Interventional
Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
NCT02780778CI-TRIAL-00022334unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）with docetaxel (60 mg/m²) in advanced Non-squamous Non-small cell lung cancer after failure of first line chemotherapy.
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 |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- Apatinib：500 mg，po，qd； Docetaxel：60mg/m²，vein input 1hour，every 3w
- interventionNames
- Drug: Apatinib
- Drug: Docetaxel
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 1 Day
Secondary outcomes (3)
- measure
- objective remission rate
- timeFrame
- 1 Day
- measure
- disease control rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 and ≤ 75 years of age * Histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer. * EGFR mutation testing negative of sensitive mutations * At least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral CT scan) * Have failed for 1 lines of chemotherapy * ECOG performance scale 0 - 1. * Life expectancy of more than 3 months. * Duration from the last therapy is more than 6 weeks for nitroso or mitomycin * More than 4 weeks after operation or radiotherapy * More than 4 weeks for cytotoxic agents * Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10\^9/L, neutrophils ≥ 1.5×10\^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min, * Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure. Exclusion Criteria: * Received more than one kind of chemotherapy regimens * NSCLC received other VEGFR inhibitors (except beacizumab) or docetaxel chemotherapy * Existing therapy related toxicity of prior chemotherapy and/or radiation therapy * Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure * Any factors that influence the usage of oral administration * The center of the tumor invaded local large blood vessels * Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3). * Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc. * Less than 4 weeks from the last clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.