Clinical trial NCT05844150: A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: SCLC
Keywords: ES-SCLC
Lead sponsor: Biotheus Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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）.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
measure: Progression free survival (PFS)
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
measure: Duration of response (DOR)
timeFrame: Up to approximately 2 years
measure: Time to response (TTR)
timeFrame: Up to approximately 2 years
measure: Pharmacokinetic (PK) parameters
timeFrame: Up to 30 days after last treatment
measure: Anti-drug antibody (ADA)
timeFrame: Up to 30 days after last treatment
measure: Treatment related adverse events (TRAEs)
timeFrame: Up to 30 days after last treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Jinan
country: China
facility: Central Hospital Affiliated To Shandong First Medical University
city: Langfang
country: China
facility: Hebei Petro China Central Hospital
city: Linyi
country: China
facility: Linyi Cancer Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shandong
country: China
facility: Shandong Cancer Hospital
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Jilin Provincial Tumor Hospital
name: Ying Cheng
role: PRINCIPAL_INVESTIGATOR
References: