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

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

Study Overview

• Status: Not yet recruiting
• Conditions: SCLC
• Intervention / Treatment: Drug: irinotecan liposome(II) plus Ivonescimab via intravenously (IV) Q3W for 4-6 cycles, followed by Ivonescimab until disease progression or intolerable toxicity

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jincheng Song, MD; Phone Number: 0411-84671291-6152; Email: wwepqwq@163.com

Study Locations

• China
  • Liaoning
    • Dalian, Liaoning, China, 116027
      • The Second Affiliated Hospital of Dalian Medical University
      • Contact: Phone Number: 0411-84671291-6152
      • Contact: Zhaoxia Dai, MD
    • Shenyang, Liaoning, China, 110022
      • Shengjing Hospital Of China Medical University
      • Contact: Wei Zheng; Phone Number: 024-96615-63211
      • Contact: Wei Zheng, MD

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Irinotecan liposome (II) combined with ivonescimab; 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	Drug: irinotecan liposome(II) plus Ivonescimab via intravenously (IV) Q3W for 4-6 cycles, followed by Ivonescimab until disease progression or intolerable toxicity; Drug: ivonescimab 20mg/kg, IV, D1, Q3W Other Names: AK112 Drug: irinotecan liposome(II) 70mg/m^2, IV, D1, Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	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).	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS is the time from the date of randomization or first dosing date to death due to any cause.	Up to approximately 2 years
Treatment related adverse events (TRAEs)	The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0	Up to 30 days after last treatment
Objective response rate（ORR）	Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.	Up to approximately 2 years
Disease control rate (DCR)	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.	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Dalian Medical University
• Collaborators: Shengjing Hospital
• Investigators: Principal Investigator: Wei Zheng, MD, Shengjing Hospital; Principal Investigator: Zhaoxia Dai, MD, The Second Affiliated Hospital of Dalian Medical University

Publications and helpful links

General Publications

• Li L, Liu T, Liu Q, Mu S, Tao H, Yang X, Li Y, Xiong Q, Wang L, Hu Y. Rechallenge of immunotherapy beyond progression in patients with extensive-stage small-cell lung cancer. Front Pharmacol. 2022 Sep 6;13:967559. doi: 10.3389/fphar.2022.967559. eCollection 2022.
• Spigel DR, Dowlati A, Chen Y, Navarro A, Yang JC, Stojanovic G, Jove M, Rich P, Andric ZG, Wu YL, Rudin CM, Chen H, Zhang L, Yeung S, Benzaghou F, Paz-Ares L, Bunn PA; RESILIENT Trial Investigators. RESILIENT Part 2: A Randomized, Open-Label Phase III Study of Liposomal Irinotecan Versus Topotecan in Adults With Relapsed Small Cell Lung Cancer. J Clin Oncol. 2024 Jul 1;42(19):2317-2326. doi: 10.1200/JCO.23.02110. Epub 2024 Apr 22.
• Chen Z, Wu L, Wang Q, Yu Y, Liu X, Ma R, Li T, Li Y, Song X, Li L, Zhao W, Wang Q, Xu X, Lu S. Brief Report: Ivonescimab Combined With Etoposide Plus Carboplatin as First-Line Treatment for Extensive-Stage SCLC: Results of a Phase 1b Clinical Trial. J Thorac Oncol. 2025 Feb;20(2):233-239. doi: 10.1016/j.jtho.2024.10.013. Epub 2024 Oct 28.

Study record dates

Study Major Dates

• Study Start (Estimated): February 28, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: SCLC，irinotecan liposome(II)，Ivonescimab
• 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; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Irinotecan
• Other Study ID Numbers: HR070803-SCLC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No