non-small-cell lung cancer
Conditions
Interventions
Treatment Arm:Anlotinib plus docetaxel
Control Arm:Docetaxel
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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. Disease progression during or after prior platinum-based chemotherapy; 4. Patients harbouring drive mutantion need to be treated by target TKI medicine and prior platinum-based chemotherapy; 5. Aged 18-75 years; 6. ECOG PS 0-2; 7. Expected Survival Time:Over 3 months; 8. Prior bevacizumab as first-line and/or maintenance therapy is allowed; 9. Patients with hydrothorax as well as measurable nidus (>1cm)were allowed; 10. Adequate organ function, defined as: Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10^3/microliters (µL), hemoglobin greater than or equal to 9.0 grams/deciliter (g/dL), and platelets greater than or equal to 800 x 10^3/µL; Total bilirubin less than or equal to 1.5 xUpper Limit of Normal (ULN), Aspartate Aminotransferase (AST) and Alanine Aminotransaminase (ALT) less than or equal to 2.5 x ULN, or less than or equal to 5 x ULN if the transferase elevation is due to liver metastases,Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance greater than or equal to 60 milliliters per minute (ml/min) (per the Cockcroft-Gault formula or equivalent and/or 24-hour urine collection), LVEF=50%; 11. 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 male patients who must agree to take contraceptive methods during the research and within another 6 months after it.
Exclusion criteria
Exclusion criteria: 1. The participant's tumor wholly or partially contains small cell lung cancer or squamous non- small cell lung cancer; 2. Non-small cell lung cancer along with hemoptysis (>50ml/day); 3. Symptoms of brain metastases cannot be controlled and treated within less than 2 months; 4. Prior therapy with docetaxel; 5. With kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus); 6. Serious illness or medical condition(s) including: Uncontrolled arterial hypertension greater than or equal to 150 / greater than or equal to 100 millimeters of mercury (mm Hg) despite standard medical management; Clinically relevant congestive heart failure [New York Heart Association (NYHA II-IV)] or symptomatic or poorly controlled cardiac arrhythmia (including QTC =480ms) myocardial ischemia or myocardial infarct; Active or uncontrolled clinically serious infection (=CTC AE grade 2); Active or chronic hepatitis need to be treated; Renal failure need to be treated by Hemodialysis or peritoneal dialysis; Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness Uncontrolled diabetes (FBG>10mmol/L); Urinary protein quantitative value=2+and quantitative protein is >1.0g in a 24 hour urine sample Active epileptic that need to be treated; 7. Take major surgical treatments, open biopsy, or get overt traumatic injury within 28 days before grouping; 8. Radiologically documented evidence of major blood vessel invasion or encasement by cancer; 9. 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); 10. Known allergy or hypersensitivity reaction to any of the treatment components; 11. Get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism; 12. Ever abuse psychiatric drugs and cannot abstain or who are diagnosed with mental disorder; 13. Persistence of clinically relevant therapy related toxicities(except alopecia) from previous chemotherapy and/or radiotherapynot recovered less than NCI-CTCAE grade 1; 14. Have participated in other clinical trials of anti-tumor medicine within 4 weeks; 15. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administrationjudged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year OS Rate;ORR;DCR;QoL; | — |
Countries
China
Contacts
Public ContactZhenzhou Yang
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed