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

NCT03059797 | Completed Phase 2

• 1 other identifier: ALTN-12-II
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progress free survival (PFS)

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

Secondary Outcomes (4)

• 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)

Study Arms (2)

Anlotinib

EXPERIMENTAL

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

Drug: Anlotinib

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Anlotinib DRUG

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

Anlotinib

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• Patients who have been used anlotinib
• Patients who have been used targeted drugs(such as sunitinib,bevacizumab,endostar),Immune targeted drugs
• 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

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (12)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

The 307th Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, 100071, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Harbin medical university affiliated tumor hospital

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 130012, China

Location

Liaoning Cancer Hospital

Shenyang, Liaoning, 110042, China

Location

Linyi Cancer Hospital

Linyi, Shandong, 276000, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Related Publications (3)

• 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.

  PMID: 34417989 DERIVED

• 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.

  PMID: 34302324 DERIVED

• 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.

  PMID: 34006926 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 23, 2017
• Study Start: March 27, 2017
• Primary Completion: June 30, 2018
• Study Completion: May 6, 2019
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

CN (12)