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

NCT05844150 | Active Not Recruiting Phase 2

• 1 other identifier: PM8002-BC011C-SCLC-R
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 17

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

Conditions

SCLC

Keywords

ES-SCLC

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

  Up to approximately 2 years

Secondary Outcomes (8)

• Overall survival (OS)

  Up to approximately 2 years

• Progression free survival (PFS)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of response (DOR)

  Up to approximately 2 years

• Time to response (TTR)

  Up to approximately 2 years

Study Arms (1)

PM8002+Etoposide＋platinum

EXPERIMENTAL

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.

Drug: PM8002; Drug: Platinum; Drug: Etoposide

Interventions

PM8002 DRUG

IV infusion

PM8002+Etoposide＋platinum

Platinum DRUG

IV infusion

PM8002+Etoposide＋platinum

Etoposide DRUG

IV infusion

PM8002+Etoposide＋platinum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotheus Inc.: lead

Study Sites (17)

Beijing Cancer Hospital

Beijing, China

Location

Jilin Cancer Hospital

Changchun, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Zhejiang Cancer Hospital

Hangzhou, China

Location

Harbin Medical University Cancer Hospital

Harbin, China

Location

Anhui Provincial Hospital

Hefei, China

Location

Central Hospital Affiliated To Shandong First Medical University

Jinan, China

Location

Hebei Petro China Central Hospital

Langfang, China

Location

Linyi Cancer Hospital

Linyi, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, China

Location

Shandong Cancer Hospital

Shandong, China

Location

Shanghai Pulmonary Hospital

Shanghai, China

Location

Taizhou Hospital of Zhejiang Province

Taizhou, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

MeSH Terms

Interventions

Platinum; Etoposide

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Ying Cheng

  Jilin Provincial Tumor Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: June 1, 2023
• Primary Completion: May 10, 2024
• Study Completion: December 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the trial completed
• Access Criteria: NCI is committed to sharing data in accordance with NIH policy.

Locations

CN (17)