A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC

Study Overview
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Brief Summary
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PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC.

Detailed Description
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This is a phase II, single arm study assessing the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy

Official Title
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A Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Paclitaxel Injection as Second Line Treatment for Small Cell Lung Cancer(SCLC)

Conditions
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SCLC

Intervention / Treatment
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* Drug: PM8002
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent form before any trial-related processes; Age ≥18 years; Histologically or cytologically confirmed SCLC; Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors; Have adequate organ function; The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1; Life expectancy of ≥12 weeks; Had at least one measurable tumor lesion according to RECIST v1.1. Exclusion Criteria: History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs; Evidence and history of severe bleeding tendency; History of severe cardiovascular diseases within 6 months; Current presence of severe superior vena cava syndrome and spinal cord compression; Current presence of uncontrolled pleural, pericardial, and peritoneal effusions; History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; History of alcohol abuse, psychotropic substance abuse or drug abuse; Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome; Pregnant or lactating women; Other conditions considered unsuitable for this study by the investigator.

Ages Eligible for Study
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Minimum Age: 18 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: PM8002+Paclitaxel<br>Subjects will be administered with PM8002 plus Paclitaxel via intravenously (IV) Q3W for 5 cycles, followed by PM8002 until disease progression or intolerable toxicity for a maximum of 2 years. | Drug: PM8002<br>* IV infusion<br>Drug: Paclitaxel<br>* IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1. | Up to approximately 2 years | 
| Treatment related adverse events (TRAEs) | The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0 | Up to 30 days after last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate (DCR) | DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1. | Up to approximately 2 years | 
| Duration of response (DoR) | DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first. | Up to approximately 2 years | 
| Progression free survival (PFS) | PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1). | Up to approximately 2 years | 
| Overall survival (OS) | OS is the time from the date of first dosing date to death due to any cause. | Up to approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Second line