Study of Anlotinib in Patients With Small Cell Lung Cancer (ALTER1202)

Study Overview
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Brief Summary
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To compare the effects and safety of Anlotinib with placebo in patients with small cell lung cancer(SCLC).

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Small Cell Lung Cancer(ALTER1202)

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Anlotinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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： Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg); 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); Patients with active or unable to control serious infections; Patients with cirrhosis, decompensated liver disease, or active hepatitis; Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anlotinib<br>Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle | Drug: Anlotinib<br>* Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle<br>|
| Placebo Comparator: Placebo<br>Placebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle | Drug: Placebo<br>* Placebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival (PFS) |  | From randomization，each 42 days up to PD or death(up to 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) |