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

A Phase II/III Clinical Trial 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

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

Study Overview

• Status: Recruiting
• Conditions: SCLC
• Intervention / Treatment: Drug: Etoposide; Drug: Atezolizumab; Drug: PM8002; Drug: Platinum

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.

The second part is randomized, double-blind study, this study plans to enroll 386 subjects, who will be randomized in a 1:1 ratio to an experimental group of PM8002 in combination with chemotherapy (etoposide and platinum) and a control group of Atezolizumab with chemotherapy (etoposide and platinum).

• Study Type: Interventional
• Enrollment (Estimated): 445
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Zhishuo Cheng; Phone Number: +86 021 32120207; Email: cheng.zs@biotheus.com

Study Locations

• China
  • Changchun, China
    • Recruiting
    • Jilin Cancer Hospital
    • Contact: Ying Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PM8002+Etoposide＋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.	Drug: Etoposide; IV infusion; Drug: PM8002; IV infusion; Drug: Platinum; IV infusion
Active Comparator: Atezolizumab+Etoposide＋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.	Drug: Etoposide; IV infusion; Drug: Atezolizumab; IV infusion; Drug: Platinum; IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (Part 1)	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
Overall survival (Part 2)	Overall survival (OS) is the time from the date of randomization or first dosing date to death due to any cause.	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to response (TTR)	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).	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
Overall survival (Only for Part 1)	OS is the time from the date of randomization or first dosing date to death due to any cause.	Up to approximately 2 years
Progression free survival (PFS)	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).	Up to approximately 2 years
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
Objective response rate (ORR) (Only for Part 2)	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
Pharmacokinetic (PK) parameters	The PK parameters including serum concentrations of PM8002 at different time points after study drug administration.	Up to 30 days after last treatment
Anti-drug antibody (ADA)	To evaluate the incidence of ADA to PM8002.	Up to 30 days after last treatment

Collaborators and Investigators

• Sponsor: Biotheus Inc.
• Investigators: Principal Investigator: Ying Cheng, Jilin Provincial Tumor Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: ES-SCLC
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Etoposide; Atezolizumab
• Other Study ID Numbers: PM8002-BC011C-SCLC-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations
• IPD Sharing Time Frame: After the trial completed
• IPD Sharing Access Criteria: NCI is committed to sharing data in accordance with NIH policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No