Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）

CTTQ

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Anlotinib; Drug: Placebo capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01924195

ALTN-03-II

Details and patient eligibility

About

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

Enrollment: 117 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

117 participants in 2 patient groups, including a placebo group

Anlotinib

Active Comparator group

Description:

Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Treatment:

Drug: Anlotinib

Placebo Capsule

Placebo Comparator group

Description:

Placebo capsule QD po and it should be continued until disease progression or patients withdrawal of consent

Treatment:

Drug: Placebo capsule