Jilin Povince Cancer Hospital
Changchun, Jilin, China
NCT Number: NCT04672928
This study is a phase Ib/III clinical study to evaluate the efficacy and safety of recombinant fully human anti-programmed cell death receptor 1 (PD-1) and anti-programmed cell death ligand 1 (PD-L1) bispecific antibody injection (IBI318) in combination with paclitaxel versus placebo in combination with paclitaxel in subjects with small cell lung cancer who have failed first-line or above chemotherapies.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Changchun, Jilin, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
80mg/m^2,iv,Q4W
300mg,iv,Q4W
Time frame: 3 months
The incidence rate of all treatment-emergent adverse events (TEAEs), immune-related adverse events (irAEs) and serious adverse events (SAEs), treatment-related adverse events (TRAEs) and the severity.
Time frame: 12 months
Proportion of subjects with complete response (CR) or partial response (PR).
Time frame: 12 months
For subjects with CR or PR, it is defined as the time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death.
Time frame: 12 months
Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).
Time frame: 12 months
Time from randomization to first objective tumor response (CR or PR).
Time frame: 12 months
Defined as the time from randomization to the first occurrence of objective disease progression or death.
Time frame: 12 months
Defined as the time from randomization to death due to any cause.
Innovent Biologics (Suzhou) Co. Ltd.
Industry
A Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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