A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC

Phase 2

Recruiting

• Conditions: SCLC
• Interventions: Drug: PM8002; Drug: Platinum; Drug: Atezolizumab; Drug: Etoposide

• 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, with a planned enrollment of at least 59 subjects.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-04-25
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-05-06
• Study Start: 2023-06-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 445

Inclusion Criteria

1. Signed informed consent form before any trial-related processes;
2. Age ≥18 years;
3. Histologically or cytologically confirmed ES-SCLC;
4. No prior systemic therapy for ES-SCLC;
5. Have adequate organ function;
6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
7. Life expectancy of ≥12 weeks;
8. Had at least one measurable tumor lesion according to RECIST v1.1.

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Exclusion Criteria

1. Histologically or cytologically confirmed mixed SCLC;
2. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
3. The toxicity of previous anti-tumor therapy has not been alleviated；
4. Have received anti-platelet therapy within 10 days prior to the first dose of the study drugs;
5. Evidence and history of severe bleeding tendency;
6. History of severe cardiovascular diseases within 6 months;
7. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
8. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
9. History of alcohol abuse, psychotropic substance abuse or drug abuse;
10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
11. Pregnant or lactating women;
12. Other conditions considered unsuitable for this study by the investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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	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.
Atezolizumab+Etoposide＋platinum	Platinum	Subjects will be administered with Atezolizumab plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by Atezolizumab 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.
Atezolizumab+Etoposide＋platinum	Atezolizumab	Subjects will be administered with Atezolizumab plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by Atezolizumab until progression or for a maximum of 2 years.
Atezolizumab+Etoposide＋platinum	Etoposide	Subjects will be administered with Atezolizumab plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by Atezolizumab until progression or for a maximum of 2 years.

Primary Outcome Measures

Name	Time	Method
Objective response rate (Part 1)	Up to approximately 2 years	Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Overall survival (Part 2)	Up to approximately 2 years	Overall survival (OS) is the time from the date of randomization or first dosing date to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Overall survival (Only for Part 1)	Up to approximately 2 years	OS is the time from the date of randomization or first dosing date to death due to any cause.
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.
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).
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.
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
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.
Anti-drug antibody (ADA)	Up to 30 days after last treatment	To evaluate the incidence of ADA to PM8002.
Objective response rate (ORR) (Only for Part 2)	Up to approximately 2 years	Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

Trial Locations

Locations (17)

Beijing Cancer Hospital; 🇨🇳 Beijing, 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

Jilin Cancer Hospital; 🇨🇳 Changchun, China