A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC
NCT ID: NCT05844150
Last Updated: 2025-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2023-06-01
2025-12-31
Brief Summary
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Detailed Description
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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）.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
PM8002
IV infusion
Platinum
IV infusion
Etoposide
IV infusion
Interventions
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PM8002
IV infusion
Platinum
IV infusion
Etoposide
IV infusion
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Biotheus Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ying Cheng
Role: PRINCIPAL_INVESTIGATOR
Jilin Provincial Tumor Hospital
Locations
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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
The First Affiliated Hospital of Nanchang University
Nanchang, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
Shandong Cancer Hospital
Shandong, , China
Shanghai Pulmonary Hospital
Shanghai, , China
Taizhou Hospital of Zhejiang Province
Taizhou, , China
Tianjin Medical University General Hospital
Tianjin, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Countries
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Other Identifiers
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PM8002-BC011C-SCLC-R
Identifier Type: -
Identifier Source: org_study_id
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