Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0303）

CTTQ

Status and phase: Completed; Phase 3; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Placebo; Drug: Anlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02388919

ALTN-03-IIB

Details and patient eligibility

About

Evaluate the efficacy and safety of Anlotinib as the 3-line treatment of patients with advanced non-small lung cancer, with placebo control.

Full description

Anlotinib (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 VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.

Enrollment: 439 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed and dated informed consent
2. Diagnosed with advanced NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
3. at least two systematic chemotherapy with upwards of 3-line treatments or cannot suffer
4. Patients must provide detectable specimen (from tumor tissue or hydrothorax) before participating, who negative in EGFR&ALK can participate or who positive in EGFR&ALK, have or have not drug tolerance after the treatment with relative targeted drugs
5. ECOG PS：0-1,Expected Survival Time: Over 3 months
6. main organs function is normal
7. The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it

Exclusion criteria

1. have used Anlotinib before
2. Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
3. examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs
4. central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
5. other kinds of malignancies within 5 years or for now
6. plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping
7. have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
8. with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
9. pleural effusion or ascites, resulting in respiratory syndrome (≥CTC AE level 2)
10. symptoms of brain metastases cannot be controlled and treated within less than 2 months
11. get any severe diseases or the ones that cannot be controlled
12. take major surgical treatments, open biopsy, or get overt traumatic injury within 28 days before grouping
13. have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding (≥CTCAE level 3)
14. get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism
15. ever abuse psychiatric drugs and cannot abstain or who are diagnosed with mental disorder
16. have participated in other clinical trials of anti-tumor medicine within 4 weeks
17. diagnosed with disease which will severely endanger the security of patients or influence the completion of this research.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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439 participants in 2 patient groups, including a placebo group

Anlotinib

Experimental group

Description:

Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent

Treatment:

Drug: Anlotinib

Placebo

Placebo Comparator group

Description:

Placebo p.o, qd and it should be continued until disease progress or patients withdraw consent

Treatment:

Drug: Placebo