NCT05844150Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 12 Mar 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 25 Apr 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 10 May 2024
- Lead sponsor
- Biotheus Inc.
- Diseases
- Lung cancer
- NCT number
- NCT05844150
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 50
- From 1 Jun 2023 to the primary completion date, 10 May 2024
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The toxicity of previous anti-tumor therapy has not been alleviated;
Other illness
- History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
- Evidence and history of severe bleeding tendency;
- History of severe cardiovascular diseases within 6 months;
- 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;
- Other conditions considered unsuitable for this study by the investigator.
Lab values
- Have received anti-platelet therapy within 10 days prior to the first dose of the study drugs;
Other
- Histologically or cytologically confirmed mixed SCLC;
- Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
- Pregnant or lactating women;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Jilin Cancer Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Central Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Hebei Petro China Central Hospital Coordinator of this site? Confirm its status | Langfang | China | Unknown status |
| LinYi Cancer Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Shandong | China | Unknown status |
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.