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

Small Cell Lung Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059797
• Other study ID #: ALTN-12-II
• Status: Completed
• Phase: Phase 2
• Start date: March 27, 2017
• Est. completion date: May 6, 2019

Study information

• Verified date: May 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 6, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	The 307th Hospital of Chinese People's Liberation Army	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Guangdong General Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Harbin medical university affiliated tumor hospital	Harbin	Heilongjiang
China	Linyi Cancer Hospital	Linyi	Shandong
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	Tianjin Medical University Cancer Hospital	Tianjin	Tianjin
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress free survival (PFS)		From randomization,each 42 days up to PD or death(up to 24 months)
Secondary	Overall Survival (OS)		From randomization until death (up to 24 months)
Secondary	Objective Response Rate (ORR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)
Secondary	Disease Control Rate (DCR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Until 30 day safety follow-up visit (up to 24 months)