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

Phase 3

Recruiting

• Conditions: SCLC
• Interventions: Drug: PM8002; Drug: Paclitaxel; Drug: Topotecan

• Registration Number: NCT06616532
• Lead Sponsor: Biotheus Inc.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-25
• Study First Posted: 2024-09-27
• Study Start: 2024-11-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-19
• Primary Completion: 2027-01-25
• Study Completion: 2028-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 404

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;

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PM8002+Paclitaxel	PM8002	Subjects will be administered with PM8002 in combination with Paclitaxel via intravenously (IV) infusion.
PM8002+Paclitaxel	Paclitaxel	Subjects will be administered with PM8002 in combination with Paclitaxel via intravenously (IV) infusion.
Chemotherapy	Paclitaxel	Subjects will be administered with Investigator's Choice(Topotecan or Paclitaxel) via intravenously (IV) infusion Q3W.
Chemotherapy	Topotecan	Subjects will be administered with Investigator's Choice(Topotecan or Paclitaxel) via intravenously (IV) infusion Q3W.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to approximately 32 months from first patient in	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.

Secondary Outcome Measures

Name	Time	Method
Health related quality of life (HRQoL)	Up to 30 days after last treatment	Differences in the scores of health-related quality of life (HRQol)
Anti-drug antibody (ADA)	Up to 30 days after last treatment	To evaluate the incidence and characteristics of ADA to PM8002
Progression-Free Survival (PFS) assessed by evaluated by investigator	Up to approximately 32 months from first patient in	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 i...
Objective response rate (ORR) evaluated by investigator	Up to approximately 32 months from first patient in	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.
Disease control rate (DCR)	Up to approximately 32 months from first patient in	DCR is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by investigators based on RECIST v1.1
Time to response (TTR)	Up to approximately 32 months from first patient in	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
Duration of response (DOR)	Up to approximately 32 months from first patient in	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.
6 month PFS rate	Up to approximately 32 months from first patient in	PFS rate corresponding to the 6th month of the progression-free survival curve
12 month PFS rate	Up to approximately 32 months from first patient in	PFS rate corresponding to the 12th month of the progression-free survival curve
12 month OS rate	Up to approximately 32 months from first patient in	OS rate corresponding to the 12th month of the overall survival curve
Incidence and severity of Adverse Event (AE) according to CTCAE 5.0	Up to 30 days after last treatment	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.

Trial Locations

Locations (11)

Jilin Provincial Tumor Hospital; 🇨🇳 Changchun, China

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China

The First Affiliated Hospital Of Ningbo University; 🇨🇳 Ningbo, Zhejiang, China

Binzhou Medical University Hospital; 🇨🇳 Binzhou, China

Jilin Cancer Hospital; 🇨🇳 Changchun, Jilin, 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