Small Cell Lung Cancer
Conditions
Brief summary
To compare the effects and safety of Anlotinib with placebo in patients with small cell lung cancer(SCLC).
Interventions
DRUGAnlotinib
Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle
DRUGPlacebo
Placebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histological documentation of small cell lung cancer * Advanced small cell lung cancer who had at least two chemotherapy regimens,at least one measurable lesion (by RECIST1.1) * 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months * Main organs function is normal * Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped * Patients should participate in the study voluntarily and sign informed consent
Exclusion criteria
* Patients who have been used anlotinib * Patients who have been used targeted drugs(such as sunitinib,bevacizumab,endostar),Immune targeted drugs * 4 weeks or less from the last cytotoxic therapy, radiation therapy or surgery * Patients whose primary lesion with active bleeding within 4 months * Carcinomatous meningitis * Patients who known to the central nervous system * Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.) * Patients with any severe and/or unable to control diseases，including： 1. Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg); 2. Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥450ms(male),QTc≥470ms（female）) and patients with Grade 1 or higher congestive heart failure (NYHA Classification); 3. Patients with active or unable to control serious infections; 4. Patients with cirrhosis, decompensated liver disease, or active hepatitis; 5. Patients with poorly controlled diabetes (fasting blood glucose(FBG)\>10mmol/L) 6. Urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed; * Patients with non-healing wounds or fractures * Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism * Patients with drug abuse history and unable to get rid of or Patients with mental disorders * Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage * History of immunodeficiency * Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress free survival (PFS) | From randomization，each 42 days up to PD or death(up to 24 months) |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | From randomization until death (up to 24 months) |
| Objective Response Rate (ORR) | each 42 days up to intolerance the toxicity or PD (up to 24 months) |
| Disease Control Rate (DCR) | each 42 days up to intolerance the toxicity or PD (up to 24 months) |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Until 30 day safety follow-up visit (up to 24 months) |
Countries
China
Outcome results
None listed