A Phase Ib/III 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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Small Cell Lung Carcinoma

Intervention / Treatment
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* Drug: paclitaxel
* Drug: IBI318


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed the Informed Consent Form; Male or female ≥ 18 and≤75 years of age; Life expectancy ≥ 12 weeks; Pathologically confirmed limited or extensive stage small cell lung cancer according to Veterans Lung Administration Lung Study Group (VALG) staging; At least had progressive disease during or after platinum-based first-line chemotherapy or chemoradiotherapy, and with clear evidence of radiographic progression. Exclusion Criteria: Previous exposure to immune-mediated therapy; previous use of taxane chemotherapy; Received the last anti-tumor therapy (chemotherapy, radiotherapy) within 4 weeks prior to the first dose of study drug; Received any investigational agent within 4 weeks prior to the first dose of study drug; Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose; Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study; Pregnant or breastfeeding woman.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI318 in combination with paclitaxel<br> | Drug: paclitaxel<br>* 80mg/m^2,iv,Q4W<br>Drug: IBI318<br>* 300mg,iv,Q4W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | 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. | 3 months | 
| Objective remission rate | Proportion of subjects with complete response (CR) or partial response (PR). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous remission time (DOR) | 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. | 12 months | 
| Disease Control Rate (DCR) | Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD). | 12 months | 
| Time to response (TTR) | Time from randomization to first objective tumor response (CR or PR). | 12 months | 
| Progression-free survival (PFS) | Defined as the time from randomization to the first occurrence of objective disease progression or death. | 12 months | 
| Overall survival (OS) | Defined as the time from randomization to death due to any cause. | 12 months |