RecruitingPhase 3NCT06616532

PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer

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

Sponsor

Biotheus Inc.

Enrollment

404 participants

Start Date

Nov 13, 2024

Study Type

INTERVENTIONAL

Conditions

SCLC

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new combination treatment — PM8002 (a bispecific antibody targeting both PD-L1 and VEGF) plus paclitaxel (a chemotherapy drug) — compared to standard chemotherapy alone, as a second treatment option for people with small cell lung cancer (SCLC) that has returned or worsened after initial treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with small cell lung cancer confirmed by biopsy or cell testing - Your cancer progressed or relapsed after first-line chemotherapy containing platinum (and if you had extensive-stage disease, you also received immunotherapy) - You are in good general health (ECOG score 0–1) - You have at least one measurable tumor - Your organs are functioning adequately - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have a history of severe allergic reactions to the study drugs - Your organs are not functioning well enough - You have active autoimmune disease or uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPM8002

Following a predefined dose and date.

DRUGPaclitaxel

175mg/m2 via IV infusion on Day 1 Q3W

DRUGTopotecan

1.25mg/m2/day via IV infusion on Days 1-5 Q3W

Locations(45)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Affiliated Hospital Of Ningbo University

Ningbo, Zhejiang, China

Binzhou Medical University Hospital

Binzhou, China

Hunan Cancer Hospital

Changsha, China

Sichuan Cancer Hospital

Chengdu, China

First People's Hospital of Chenzhou

Chenzhou, China

The First Affiliated Hospital of Army Medical University

Chongqing, China

The Second Hospital of Dalian Medical University

Dalian, China

The First People's Hospital of Foshan

Foshan, China

Fujian Cancer Hospital

Fuzhou, China

The Affiliated Hospital Of Guilin Medical University

Guilin, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Anhui Province Hospital

Hefei, China

Shandong Cancer Institute

Jinan, China

Jingzhou First People's Hospital

Jingzhou, China

Affiliated Hospital of Jining Medical University

Jining, China

Yunnan Cancer Hospital

Kunming, China

Liuzhou People's Hospital

Liuzhou, China

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, China

Meizhou People's Hospital

Meizhou, China

Mianyang Central Hospital

Mianyang, China

Jiangxi Cancer Hospital

Nanchang, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Nanchong Central Hospital

Nanchong, China

Jiangsu Province Hospital

Nanjing, China

Nanjing Drum-Tower Hospital

Nanjing, China

Guangxi Medical University Cancer Hospital

Nanning, China

Nanyang Central Hospital

Nanyang, China

Qujing NO.1 Hospital

Qujing, China

The Fourth Hospital of Hebei Medical University

Shijia Zhuang, China

Taizhou Enze Medical Center (group)

Taizhou, China

Weifang NO.2 People's Hospital

Weifang, China

Weihai Municipal Hospital

Weihai, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Zhongnan Hospital Of Wuhan University

Wuhan, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Xiangyang Central Hospital

Xiangyang, China

Xuzhou Central Hospital

Xuzhou, China

The Second People's Hospital Of Yibin

Yibin, China

Yongzhou Central Hospital

Yongzhou, China

Yuncheng City Center Hospital

Yuncheng, China

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, China

Zhoukou Central Hospital

Zhoukou, China

View Full Details on ClinicalTrials.gov

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