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

• ClinicalTrials.gov Identifier: NCT03059797
• Recruitment Status: Completed
• First Posted: February 23, 2017
• Last Update Posted: May 16, 2019
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Information provided by (Responsible Party): Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Tracking Information

• First Submitted Date: February 16, 2017
• First Posted Date: February 23, 2017
• Last Update Posted Date: May 16, 2019
• Actual Study Start Date: March 27, 2017
• Actual Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 16, 2017): Progress free survival (PFS) [ Time Frame: From randomization，each 42 days up to PD or death(up to 24 months) ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 16, 2017)

• Overall Survival (OS) [ Time Frame: From randomization until death (up to 24 months) ]
• Objective Response Rate (ORR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]
• Disease Control Rate (DCR) [ Time Frame: 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 [ Time Frame: Until 30 day safety follow-up visit (up to 24 months) ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Anlotinib in Patients With Small Cell Lung Cancer (ALTER1202)
• 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)
• Brief Summary: To compare the effects and safety of Anlotinib with placebo in patients with small cell lung cancer(SCLC).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Small Cell Lung Cancer

Intervention

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

Study Arms

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

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 23, 2018): 120
• Original Estimated Enrollment (submitted: February 16, 2017): 90
• Actual Study Completion Date: May 6, 2019
• Actual Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03059797
• Other Study ID Numbers: ALTN-12-II
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Verification Date: May 2019