Clinical trial · Interventional
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
NCT05844150CI-TRIAL-00087073active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SCLC | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PM8002+Etoposide+platinum
- description
- 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.
- interventionNames
- Drug: PM8002
- Drug: Platinum
- Drug: Etoposide
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- Up to approximately 2 years
- description
- ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Secondary outcomes (8)
- measure
- Overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.