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)

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.12 sites in 1 country120 target enrollmentMarch 27, 2017

Overview

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

Registry

clinicaltrials.gov

Start Date

March 27, 2017

End Date

May 6, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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);

Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle

Intervention: Anlotinib

Placebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle

Intervention: Placebo

Progress free survival (PFS)

Time Frame: From randomization，each 42 days up to PD or death(up to 24 months)

Overall Survival (OS)(From randomization until death (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))
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))