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A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

A Phase II 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

NCT05844150•Biotheus Inc.

View on ClinicalTrials.gov

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）.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

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

Key Dates

Start Date

June 1, 2023

Primary Completion Date

May 10, 2024

Completion Date

December 1, 2025

Last Updated

March 12, 2025

Enrollment

ACTUAL participants

Conditions

SCLC

Interventions

PM8002

DRUG

Platinum

DRUG

Etoposide

DRUG

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

View study

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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RECRUITINGPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Magnetic Resonance Imaging of the Lung: Oncological Applications

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors