Clinical trial NCT06616532: PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer
Official title: A Multicenter, Open-lable, Randomized Phase III Study of PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: SCLC
Keywords: Second-line
Lead sponsor: Biotheus Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel as second-line treatment for SCLC

Detailed description: This multicenter, randomized, open-label phase III study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel versus Investigator's Choice (Topotecan or Paclitaxel) as second-line treatment for subjects with SCLC.

Eligibility criteria: Inclusion Criteria:

1. Voluntary participation in this clinical study; full understanding of the study and voluntary signing the informed consent form; willing to follow and abling to complete all trial procedures;
2. Age ≥18 years but ≤75 years;
3. Histologically or cytologically confirmed SCLC;
4. Advanced SCLC that has progressed or replased after first-line platinum-containing chemotherapy (extensive-stage patients must have received immune checkpoint inhibitors);
5. Having adequate organ functions;
6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
7. Life expectancy of 12 weeks or more;
8. Having at least one measurable tumor lesion according to RECIST v1.1;

Exclusion Criteria:

1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
2. Previous treatment with Paclitaxel or Topotecan or anti-vascular endothelial growth factor (VEGF) target drugs;
3. Current presence of severe superior vena cava syndrome and spinal cord compression;
4. Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below;
5. Evidence of significant clotting disorder or other significant bleeding risk;
6. History of severe, uncontrollable, or active cardiovascular diseases within 6 months;
7. Current presence of uncontrollable pleural, pericardial, and peritoneal effusions;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
9. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
10. History of alcohol abuse, psychotropic substance abuse or drug abuse;
11. Pregnant or lactating women;
12. Other conditions considered unsuitable for this study by the investigator.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 32 months from first patient in
Secondary outcomes:
measure: Progression-Free Survival (PFS) assessed by evaluated by investigator
timeFrame: Up to approximately 32 months from first patient in
measure: Objective response rate (ORR) evaluated by investigator
timeFrame: Up to approximately 32 months from first patient in
measure: Disease control rate (DCR)
timeFrame: Up to approximately 32 months from first patient in
measure: Time to response (TTR)
timeFrame: Up to approximately 32 months from first patient in
measure: Duration of response (DOR)
timeFrame: Up to approximately 32 months from first patient in
measure: 6 month PFS rate
timeFrame: Up to approximately 32 months from first patient in
measure: 12 month PFS rate
timeFrame: Up to approximately 32 months from first patient in
measure: 12 month OS rate
timeFrame: Up to approximately 32 months from first patient in
measure: Incidence and severity of Adverse Event (AE) according to CTCAE 5.0
timeFrame: Up to 30 days after last treatment
measure: Anti-drug antibody (ADA)
timeFrame: Up to 30 days after last treatment
measure: Health related quality of life (HRQoL)
timeFrame: Up to 30 days after last treatment
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Ningbo
country: China
facility: The First Affiliated Hospital Of Ningbo University
state: Zhejiang
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Chenzhou
country: China
facility: First People's Hospital of Chenzhou
city: Chongqing
country: China
facility: The First Affiliated Hospital of Army Medical University
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guilin
country: China
facility: The Affiliated Hospital Of Guilin 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 Province Hospital
city: Jinan
country: China
facility: Shandong Cancer Institute
city: Jingzhou
country: China
facility: Jingzhou First People's Hospital
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science & Technology
city: Meizhou
country: China
facility: Meizhou People's Hospital
city: Mianyang
country: China
facility: Mianyang Central Hospital
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanchong
country: China
facility: Nanchong Central Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: Nanjing Drum-Tower Hospital
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
city: Nanyang
country: China
facility: Nanyang Central Hospital
city: Qujing
country: China
facility: Qujing NO.1 Hospital
city: Shijia Zhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Taizhou
country: China
facility: Taizhou Enze Medical Center (group)
city: Weifang
country: China
facility: Weifang NO.2 People's Hospital
city: Weihai
country: China
facility: Weihai Municipal Hospital
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Zhongnan Hospital Of Wuhan University
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
city: Yibin
country: China
facility: The Second People's Hospital Of Yibin
city: Yongzhou
country: China
facility: Yongzhou Central Hospital
city: Yuncheng
country: China
facility: Yuncheng City Center Hospital
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital of Fujian Province
city: Zhoukou
country: China
facility: Zhoukou Central Hospital
Study officials:
affiliation: Jilin Provincial Tumor Hospital
name: Ying Cheng
role: PRINCIPAL_INVESTIGATOR
References: