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Sintilimab Combined With Anlotinib as Second or Further-line Therapy for ED-SCLC

NCT04055792 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-06-28

No results posted yet for this study

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%.

Conditions

  • Extensive Disease Small Cell Lung Cancer

Interventions

DRUG

Sintilimab

Sintilimab 200mg intravenously on day 1 and Anlotinib 12 mg on days 1-14 once every 3 weeks

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Qiming Wang · 127 Dongming Road, Zhengzhou, 450008, People's Republic of China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-11
Primary Completion
2023-05-01
Completion
2023-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04055792 on ClinicalTrials.gov