Clinical Study of First-line Treatment of Small Cell Lung Cancer (SCLC) With Anlotinib Hydrochloride
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
This study was designed to investigate the efficacy and side effects of combining erlotinib with classical EC/EP chemotherapy regimens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedMarch 26, 2019
March 1, 2019
1 year
March 24, 2019
March 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
PFS
progression-free survival
nine months
Secondary Outcomes (4)
OS
12 months
ORR
12 months
DCR
12 months
safety assessed by Adverse reactions
12 months
Study Arms (1)
Clinical trial group
EXPERIMENTAL（Carboplatin/cisplatin + etoposide）+ （Anlotinib Hydrochloride 12 mg/day ，Each cycle was defined as 2 weeks on-treatment fol- lowed by 1 week off-treatment）, after 4-6 cycles of treatment, the treatment was continued with anlotinib until disease progression.
Interventions
Eligibility Criteria
You may qualify if:
- patients 18-75 years of age.
- A metastatic or recurrent advanced SCLC confirmed by histology or cytology and did not receive any other treatment;
- a measurable disease
- an Eastern Cooperative Oncology Group PS of 0-1;
- an estimated survival duration of \>6 months;
You may not qualify if:
- Have used erlotinib or other anti-vascular targeted drugs (eg, Endo, bevacizumab, etc.)2. Patients who have been treated with chemotherapy or radiotherapy for previous tumors.3.Have appeared or merged with other tumors within 5 years.4.Patients with no measurable lesions; 5.any severe and uncontrolled disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Han JY, Kim HY, Lim KY, Han JH, Lee YJ, Kwak MH, Kim HJ, Yun T, Kim HT, Lee JS. A phase II study of sunitinib in patients with relapsed or refractory small cell lung cancer. Lung Cancer. 2013 Feb;79(2):137-42. doi: 10.1016/j.lungcan.2012.09.019. Epub 2012 Nov 20.
PMID: 23182663RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2019
First Posted
March 26, 2019
Study Start
April 1, 2019
Primary Completion
April 1, 2020
Study Completion
October 1, 2020
Last Updated
March 26, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share