Clinical trial · Interventional
Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) as Third Line Treatment in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）
- 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)
Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of andvanced non-small cell lung cancer who failed two lines of 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 |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
| Placebo capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Anlotinib
- description
- Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- interventionNames
- Drug: Anlotinib
- type
- PLACEBO_COMPARATOR
- label
- Placebo Capsule
- description
- Placebo capsule QD po and it should be continued until disease progression or patients withdrawal of consent
- interventionNames
- Drug: Placebo capsule
Primary outcomes (1)
- measure
- enhanced CT/MRI scan
- timeFrame
- each 42 days up to disease progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. pathology diagnosed with advanced NSCL with measurable lesions; 2. Have failed for 2 lines of chemotherapy; 3. 18-70years,ECOG PS:0-2,Life expectancy of more than 3 months; 4. Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks; 5. main organs function is normal; 6. must be agreed to take contraceptive measures during the study and within 6 months after end. Exclusion Criteria: 1. SCLC(including mixed with NSCLC); 2. the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC; 3. patients failed to use the anti-tumor angiogenesis therapy; 4. patients has many influence factors toward oral medications ; 5. Brain metastases patients accompanied by symptoms or symptom control for less than two months; 6. patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)\>10mmol/L);urine protein≥++,etc. 7. patients failed to heal wounds or fractures for Long-term; 8. 4 weeks before enrollment, patients appeared NCI CTC AE grading \>1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared NCI CTC AE grade\> 2 have other parts of the bleeding; patients has a tendency to bleed (eg active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues; 9. patients occurred venous thromboembolic events within 6 months; 10. patients has HIV-positive or organ transplantation;
References
Publications (0)
Data not yet available