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

Last updated: March 9, 2025
Sponsor: Biotheus Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Small Cell Lung Cancer

Treatment

Atezolizumab

Platinum

PM8002

Clinical Study ID

NCT05844150
PM8002-BC011C-SCLC-R
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Histologically or cytologically confirmed mixed SCLC;

  2. History of severe allergic disease, severe drug allergy or have known allergy to anycomponent 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 thestudy 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 organtransplantation;

  9. History of alcohol abuse, psychotropic substance abuse or drug abuse;

  10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiencysyndrome;

  11. Pregnant or lactating women;

  12. Other conditions considered unsuitable for this study by the investigator.

Study Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: Atezolizumab
Phase: 2
Study Start date:
June 01, 2023
Estimated Completion Date:
December 31, 2025

Study 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).

Connect with a study center

  • Beijing Cancer Hospital

    Beijing,
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun,
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing,
    China

    Site Not Available

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou,
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou,
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin,
    China

    Site Not Available

  • Anhui Provincial Hospital

    Hefei,
    China

    Site Not Available

  • Central Hospital Affiliated To Shandong First Medical University

    Jinan,
    China

    Site Not Available

  • Hebei Petro China Central Hospital

    Langfang,
    China

    Site Not Available

  • Linyi Cancer Hospital

    Linyi,
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University

    Qingdao,
    China

    Site Not Available

  • Shandong Cancer Hospital

    Shandong,
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai,
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Taizhou,
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin,
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.