Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-02 @ 4:22 AM
Study NCT ID:
NCT04055792
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2019-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sintilimab Combined With Anlotinib as Second or Further-line Therapy for ED-SCLC
Sponsor:
Henan Cancer Hospital
Organization:
Study Overview
Official Title:
Sintilimab Combined With Anlotinib as Second- or Further-line Therapy for Extensive Disease Small Cell Lung Cancer: A Prospective, Single-arm, Phase II Study
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Small cell lung cancer (SCLC) accounts for 10-15% of lung cancer. More than 70% of SCLC patients are diagnosed with advanced stage (ED-SCLC) at diagnosis. ED-SCLC is highly chemo-sensitive, the first-line treatment is platinum-containing double-drug chemotherapy. Although ED-SCLC is highly sensitive to chemotherapy and the objective response rate (ORR) of first-line chemotherapy is as high as 60-80%, the progression-free survival (PFS) is very short, and there is a lack of effective second-line treatment. The median overall survival (OS) of patients is only 10 months, and the 2-year survival rate is about 6%.
Detailed Description:
In August 2018, the FDA approved Nivolumab as a third-line treatment for ED-SCLC patients. Sintilimab is another PD-1 inhibitor produced by China and has been approved by cFDA for lymphoma. Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) with effect of anti-tumor angiogenesis and tumor growth inhibition. The results of ALTER1202 showed that compared with placebo, Anlotinib single-agent as third-line treatment in ED-SCLC was effective, the median PFS was 4.1 versus 0.7 months, respectively (P \< 0.001).
Immunotherapy combined with anti-angiogenic therapy has been proven effective and tolerable in non-small cell lung caner (NSCLC), while its efficacy and safety in SCLC has not been reported. Therefore, the investigators conduct this study to evaluate the efficacy and safety of Sintilimab combined with Anlotinib as second or further-line therapy for ED-SCLC patients.
Immunotherapy combined with anti-angiogenic therapy has been proven effective and tolerable in non-small cell lung caner (NSCLC), while its efficacy and safety in SCLC has not been reported. Therefore, the investigators conduct this study to evaluate the efficacy and safety of Sintilimab combined with Anlotinib as second or further-line therapy for ED-SCLC patients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: