Clinical trial · Interventional
Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC
Clinical Study of Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC After Failure of Platinum-based Double-drug Therapy
NCT03411967CI-TRIAL-00031395unknownPhase 2ClinicalTrials.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)
In order to explore a new treatment strategy for patients with failed NSCLC platinum-containing double-drug therapy, this study was to investigate the clinical efficacy of apatinib in combination with docetaxel for patients with advanced NSCLC after failure of platinum-based regime
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- apatinib combine with docetaxel
- description
- Docetaxel, 60 mg / m2, d1, iv + apatinib 500mg, po, qd
- interventionNames
- Drug: Apatinib
- Drug: Docetaxel
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 6 month
- description
- Objective Response Rate
Secondary outcomes (1)
- measure
- PFS
- timeFrame
- 12 month
- description
- Progress-Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ECOG 0-2; 2. Expected survival of not less than 12 weeks; 3. The first line of platinum-containing chemotherapy, pathologically confirmed IIIB, IV non-small cell lung cancer, with measurable lesions (according to the RECIST 1.1 standard, CT lesion tumor diameter ≥ 10mm, lymph node lesion CT scan diameter ≥ 15mm, measurable lesions have not received radiotherapy, local treatment such as freezing) 4. The main organs function properly 5. Women of childbearing age must have had reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and are willing to take appropriate measures 8 weeks after and during the last administration of the test drug contraception. In the case of males, consent is to be given to contraception or surgical sterilization 8 weeks after and during the last administration of the test drug; 6. Participants volunteered to join the study and signed informed consent form, with good compliance and follow-up. Exclusion Criteria: 1. Imaging (CT or MRI) showed tumor lesions away from the large blood vessels ≤ 5mm, or the presence of invasive central local blood vessels of the central tumor; or showed the presence of significant lung empty or necrotic tumors; 2. Uncontrolled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal drug therapy); 3. Has the following cardiovascular disease: Myocardial ischemia or myocardial infarction with grade II or higher, poorly controlled arrhythmia (including QTc intercourse men ≥ 450ms, women ≥ 470ms); NYHA class III-IV cardiomyopathy, Or cardiac ultrasound examination prompted left ventricular ejection fraction (LVEF) \<50%; 4. Hemoptysis (INR\> 1.5 or Prothrombin Time (PT)\> ULN + 4 seconds or APTT\> 1.5ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 5. In the first 2 months before enrollment, there is obvious slightly blood, or daily hemoptysis volume of 2.5ml or more; 6. Within 3 months prior to enrollment, significant clinically significant bleeding symptoms or definite bleeding tendencies such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ at baseline, and above, or vasculitis; 7. Incidence of arterial / venous thrombosis within the first 12 months of enrollment such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 8. Known hereditary or acquired bleeding and thrombophilia (eg hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc); 9. Factors that significantly affect the absorption of oral drugs, such as non-swallowing, chronic diarrhea and intestinal obstruction; 10. Urine routine urinary protein ≥ ++, or confirmed 24-hour urinary protein content ≥ 2.0g; 11. Previous or concurrent with other unhealed malignancies, except for those having had a cure for cutaneous basal cell carcinoma, carcinoma of the cervix, and superficial bladder cancer; 12. Pregnant or lactating women; Reproductive patients who are unwilling or unable to take effective contraception; 13. The investigators determine other situations that may affect clinical research and outcome decisions.
References
Publications (0)
Data not yet available
No reference posted for this study.