Study of Anlotinib in Patients With Small Cell Lung Cancer (ALTER1202)
NCT ID: NCT03059797
Last Updated: 2019-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2017-03-27
2019-05-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anlotinib
Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle
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
Placebo
Placebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The 307th Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 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
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jilin Cancer Hospital
Changchun, Jilin, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Linyi Cancer Hospital
Linyi, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
Countries
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References
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Gong J, Wan Q, Shang J, Qian X, Su D, Sun Z, Liu G. Cost-Effectiveness Analysis of Anlotinib as Third- or Further-Line Treatment for Relapsed Small Cell Lung Cancer (SCLC) in China. Adv Ther. 2021 Oct;38(10):5116-5126. doi: 10.1007/s12325-021-01889-2. Epub 2021 Aug 21.
Zhang C, Wang J, Wang X, Meng Z, Cheng Y, Li K. Peripheral blood indices to predict PFS/OS with anlotinib as a subsequent treatment in advanced small-cell lung cancer. Cancer Biol Med. 2021 Jul 24;19(8):1249-58. doi: 10.20892/j.issn.2095-3941.2020.0727.
Cheng Y, Wang Q, Li K, Shi J, Liu Y, Wu L, Han B, Chen G, He J, Wang J, Lou D, Yu H, Wang S, Qin H, Li X. Anlotinib vs placebo as third- or further-line treatment for patients with small cell lung cancer: a randomised, double-blind, placebo-controlled Phase 2 study. Br J Cancer. 2021 Aug;125(3):366-371. doi: 10.1038/s41416-021-01356-3. Epub 2021 May 18.
Other Identifiers
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ALTN-12-II
Identifier Type: -
Identifier Source: org_study_id
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