A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC
- Registration Number
- NCT05844150
- Lead Sponsor
- Biotheus Inc.
- Brief Summary
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the efficacy and safety of PM8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer
- Detailed Description
The study is divided into two parts.
The first part is single-arm study, 50 participants were enrolled as of 21 Nov 2023，and recruitment was completed.
The second part is randomized, double-blind study, active controlled design , which will be integrated to another global III study （NCT06712355）.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Signed informed consent form before any trial-related processes;
- Age ≥18 years;
- Histologically or cytologically confirmed ES-SCLC;
- No prior systemic therapy for ES-SCLC;
- 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.
- Histologically or cytologically confirmed mixed SCLC;
- History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
- The toxicity of previous anti-tumor therapy has not been alleviated；
- Have received anti-platelet therapy within 10 days prior to the first dose of the study drugs;
- Evidence and history of severe bleeding tendency;
- History of severe cardiovascular diseases within 6 months;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PM8002+Etoposide＋platinum PM8002 Subjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years. PM8002+Etoposide＋platinum Platinum Subjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years. PM8002+Etoposide＋platinum Etoposide Subjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years.
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) Up to approximately 2 years ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Up to approximately 2 years OS is the time from the date of randomization or first dosing date to death due to any cause.
Progression free survival (PFS) Up to approximately 2 years Progression free survival (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).
Disease control rate (DCR) Up to approximately 2 years DCR is defined as the proportion of subjects with CR, PR, or stable disease (SD) based on RECIST v1.1.
Duration of response (DOR) Up to approximately 2 years 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.
Time to response (TTR) Up to approximately 2 years TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieve CR or PR (based on RECIST v1.1).
Pharmacokinetic (PK) parameters Up to 30 days after last treatment The PK parameters including serum concentrations of PM8002 at different time points after study drug administration.
Anti-drug antibody (ADA) Up to 30 days after last treatment To evaluate the incidence of ADA to PM8002.
Treatment related adverse events (TRAEs) Up to 30 days after last treatment The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Trial Locations
- Locations (17)
Beijing Cancer Hospital
🇨🇳Beijing, China
Jilin Cancer Hospital
🇨🇳Changchun, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
Anhui Provincial Hospital
🇨🇳Hefei, China
Central Hospital Affiliated To Shandong First Medical University
🇨🇳Jinan, China
Hebei Petro China Central Hospital
🇨🇳Langfang, China
Linyi Cancer Hospital
🇨🇳Linyi, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, China
Shandong Cancer Hospital
🇨🇳Shandong, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China