Irinotecan Liposome(II) Combined with Ivonescimab As Second-line Treatment for Small Cell Lung Cancer : a Prospective, Single-arm, Multicenter Clinical Study

Phase 2

Not yet recruiting

• Conditions: SCLC
• Interventions: Drug: irinotecan liposome(II) plus Ivonescimab via intravenously (IV) Q3W for 4-6 cycles, followed by Ivonescimab until disease progression or intolerable toxicity

• Registration Number: NCT06820762
• Lead Sponsor: The Second Affiliated Hospital of Dalian Medical University

Brief Summary

This study will evaluate the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC.

Detailed Description

This is a prospective, single-arm, multicenter clinical study assessing the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Study Start: 2025-02-28
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age ≥18 years;
2. Histologically or cytologically confirmed SCLC;
3. Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
4. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
5. Life expectancy of ≥3 months;
6. At least one measurable lesion is present according to the efficacy evaluation criteria for RECIST 1.1（Lesions that have received radiotherapy within 6 months prior to the first dose cannot be used as target lesions）
7. No untreated central nervous system (CNS) metastases or CNS were stable for ≥1 month after treatment
8. Have adequate organ function;
9. All female must have had a negative serum pregnancy test within 72 hours of the first dosing and not be lactating, and study participants and their partners must use effective contraception during the trial and for 6 months after the last dosing of the trial drug.
10. Able and willing to provide a written informed consent;

Exclusion Criteria

1. Known allergy to irinotecan hydrochloride liposome injection (II) and eboxizumab or drug excipients
2. History of severe active autoimmune disease
3. Participated in other drug studies within 4 weeks before enrollment
4. Imaging during the screening period showed that the tumor surrounded important blood vessels or had significant necrosis and voids, and the investigators determined that entering the study would cause bleeding risk
5. History of major illness within 1 year before the first medication
6. History of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistula, intraperitoneal abscess, or acute gastrointestinal bleeding within 6 months prior to initial administration
7. History of surgery or severe trauma within 4 weeks prior to initial dosing
8. Evidence and history of severe bleeding tendency;
9. Participants who had received or planned to receive a live vaccine within 4 weeks prior to the first study treatment
10. Patients with other cancer in 3 years,exceptions are adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
11. History of alcohol abuse, psychotropic substance abuse or drug abuse. Other conditions considered unsuitable for this study by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Irinotecan liposome (II) combined with ivonescimab	irinotecan liposome(II) plus Ivonescimab via intravenously (IV) Q3W for 4-6 cycles, followed by Ivonescimab until disease progression or intolerable toxicity	Subjects will be administered with irinotecan liposome(II) plus Ivonescimab via intravenously (IV) Q3W for 4-6 cycles, followed by Ivonescimab until disease progression or intolerable toxicity

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	Up to approximately 2 years	PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).

Secondary Outcome Measures

Name	Time	Method
Objective response rate（ORR）	Up to approximately 2 years	Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Overall survival (OS)	Up to approximately 2 years	OS is the time from the date of randomization or first dosing date to death due to any cause.
Disease control rate (DCR)	Up to approximately 2 years	DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks), based on RECIST v1.1.
Treatment related adverse events (TRAEs)	Up to 30 days after last treatment	The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0

Trial Locations

Locations (2)

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

The Second Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China