Status:
COMPLETED
Safety and Efficacy Study of First-line Treatment With QL1706 Plus Chemotherapy in Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Extensive-stage Small-cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is an open label, phase 2 clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetic (PK) profile, and immunogenicity of QL1706 plus carboplatin and etoposide as first-line th...
Eligibility Criteria
Inclusion
- Subjects participate voluntarily and sign informed consent.
- Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system)
- No prior systemic treatment for ES-SCLC
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function
Exclusion
- Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
- Active, known or suspected autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, radiation pneumonia requiring steroid treatment or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
- Significant cardiovascular disease
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05309629
Start Date
April 18 2022
End Date
December 13 2024
Last Update
January 17 2025
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022