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

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

Study Overview

• Status: Active, not recruiting
• Conditions: SCLC
• Intervention / Treatment: Drug: PM8002; Drug: Paclitaxel; Drug: Topotecan

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.

• Study Type: Interventional
• Enrollment (Estimated): 404
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Binzhou, China
    • Binzhou Medical University Hospital
  • Changchun, China
    • Jilin cancer hospital
  • Changsha, China
    • Hunan Cancer Hospital
  • Chengdu, China
    • Sichuan Cancer Hospital
  • Chenzhou, China
    • First People's Hospital of Chenzhou
  • Chongqing, China
    • The First Affiliated Hospital of Army Medical University
  • Dalian, China
    • The Second Hospital of Dalian Medical University
  • Foshan, China
    • The First People's Hospital of Foshan
  • Fuzhou, China
    • Fujian Cancer Hospital
  • Guilin, China
    • The Affiliated Hospital of Guilin Medical University
  • Hangzhou, China
    • Zhejiang Cancer Hospital
  • Harbin, China
    • Harbin Medical University Cancer Hospital
  • Hefei, China
    • Anhui province hospital
  • Jinan, China
    • Shandong Cancer Institute
  • Jingzhou, China
    • Jingzhou First People's Hospital
  • Jining, China
    • Affiliated Hospital of Jining Medical University
  • Kunming, China
    • Yunnan Cancer Hospital
  • Liuzhou, China
    • Liuzhou People's Hospital
  • Luoyang, China
    • The First Affiliated Hospital of Henan University of Science & Technology
  • Meizhou, China
    • Meizhou People's Hospital
  • Mianyang, China
    • Mianyang Central Hospital
  • Nanchang, China
    • The First Affiliated Hospital of Nanchang University
  • Nanchang, China
    • Jiangxi Cancer Hospital
  • Nanchong, China
    • Nanchong Central Hospital
  • Nanjing, China
    • Jiangsu Province Hospital
  • Nanjing, China
    • Nanjing Drum-Tower Hospital
  • Nanning, China
    • Guangxi Medical University Cancer Hospital
  • Nantong, China
    • Affiliated Hospital of Nantong University
  • Nanyang, China
    • Nanyang Central Hospital
  • Ningbo, China
    • The First Affiliated Hospital of Ningbo University
  • Qujing, China
    • Qujing NO.1 Hospital
  • Shijia Zhuang, China
    • The Fourth Hospital of Hebei Medical University
  • Taizhou, China
    • Taizhou Enze Medical Center (group)
  • Weifang, China
    • Weifang NO.2 People's Hospital
  • Weihai, China
    • Weihai Municipal Hospital
  • Wuhan, China
    • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan, China
    • Zhongnan Hospital of Wuhan University
  • Xi'an, China
    • The First Affiliated Hospital of Xi'an Jiaotong University
  • Xiangyang, China
    • Xiangyang Central Hospital
  • Xuzhou, China
    • Xuzhou Central Hospital
  • Yibin, China
    • The Second People's Hospital of Yibin
  • Yongzhou, China
    • Yongzhou Central Hospital
  • Yuncheng, China
    • Yuncheng City Center Hospital
  • Zhangzhou, China
    • Zhangzhou Municipal Hospital of Fujian Province
  • Zhoukou, China
    • Zhoukou Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PM8002+Paclitaxel; Subjects will be administered with PM8002 in combination with Paclitaxel via intravenously (IV) infusion.	Drug: PM8002; Following a predefined dose and date.; Drug: Paclitaxel; 175mg/m2 via IV infusion on Day 1 Q3W
Active Comparator: Chemotherapy; Subjects will be administered with Investigator's Choice(Topotecan or Paclitaxel) via intravenously (IV) infusion Q3W.	Drug: Paclitaxel; 175mg/m2 via IV infusion on Day 1 Q3W; Drug: Topotecan; 1.25mg/m2/day via IV infusion on Days 1-5 Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis are censored at the date of the last follow-up.	Up to approximately 32 months from first patient in

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of Adverse Event (AE) according to CTCAE 5.0	An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.	Up to 30 days after last treatment
Progression-Free Survival (PFS) assessed by evaluated by investigator	PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by investigator or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.	Up to approximately 32 months from first patient in
Objective response rate (ORR) evaluated by investigator	ORR is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by investigators based on RECIST 1.1 is presented.	Up to approximately 32 months from first patient in
Disease control rate (DCR)	DCR is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by investigators based on RECIST v1.1	Up to approximately 32 months from first patient in
Time to response (TTR)	Time to response(TTR) is defined as the time from randomization to the first documented PR or CR assssed by investigator based on RECIST v1.1	Up to approximately 32 months from first patient in
Duration of response (DOR)	DoR is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first.	Up to approximately 32 months from first patient in
6 month PFS rate	PFS rate corresponding to the 6th month of the progression-free survival curve	Up to approximately 32 months from first patient in
12 month PFS rate	PFS rate corresponding to the 12th month of the progression-free survival curve	Up to approximately 32 months from first patient in
12 month OS rate	OS rate corresponding to the 12th month of the overall survival curve	Up to approximately 32 months from first patient in
Anti-drug antibody (ADA)	To evaluate the incidence and characteristics of ADA to PM8002	Up to 30 days after last treatment
Health related quality of life (HRQoL)	Differences in the scores of health-related quality of life (HRQol)	Up to 30 days after last treatment

Collaborators and Investigators

• Sponsor: Biotheus Inc.
• Investigators: Principal Investigator: Caicun Zhou, Shanghai East Hospital; Principal Investigator: Haifeng Liu, Jilin Provincial Tumor Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): December 25, 2028

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Second-line
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Organic Chemicals; Heterocyclic Compounds; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Camptothecin; Alkaloids; Taxoids; Cyclodecanes; Diterpenes; Paclitaxel; Topotecan
• Other Study ID Numbers: PM8002-C014C-SCLC-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations.
• IPD Sharing Time Frame: After the trial completed.
• IPD Sharing Access Criteria: NCI is committed to sharing data in accordance with NIH policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No