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Clinical Trial NCT05844150 for SCLC is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC Phase 2 50

Active, not recruiting
Clinical Trial NCT05844150 is designed to study Treatment for SCLC. It is a Phase 2 interventional study that is active, not recruiting, having started on June 1, 2023, with plans to enroll 50 participants. Led by Biotheus Inc., it is expected to complete by December 1, 2025. The latest data from ClinicalTrials.gov was last updated on March 12, 2025.
Brief 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）.

Official Title

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

Conditions
SCLC
Other Study IDs
  • PM8002-BC011C-SCLC-R
NCT ID Number
NCT05844150
Start Date (Actual)
2023-06-01
Last Update Posted
2025-03-12
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
ES-SCLC
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPM8002+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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Objective response rate (ORR)
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Up to approximately 2 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall survival (OS)
OS is the time from the date of randomization or first dosing date to death due to any cause.
Up to approximately 2 years
Progression free survival (PFS)
Progression free survival (PFS) is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).
Up to approximately 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or stable disease (SD) based on RECIST v1.1.
Up to approximately 2 years
Duration of response (DOR)
DOR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.
Up to approximately 2 years
Time to response (TTR)
TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieve CR or PR (based on RECIST v1.1).
Up to approximately 2 years
Pharmacokinetic (PK) parameters
The PK parameters including serum concentrations of PM8002 at different time points after study drug administration.
Up to 30 days after last treatment
Anti-drug antibody (ADA)
To evaluate the incidence of ADA to PM8002.
Up to 30 days after last treatment
Treatment related adverse events (TRAEs)
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Up to 30 days after last treatment
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
Biotheus Inc. logoBiotheus Inc.
No contact data.
17 Study Locations in 1 Countries
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