Clinical trial NCT06820762: Irinotecan Liposome(II) Combined With Ivonescimab as Second-line Treatment for Small Cell Lung Cancer : A Prospective, Single-arm, Multicenter Clinical Study
Official title: Irinotecan Liposome(II) Combined With Ivonescimab as Second-line Treatment for Small Cell Lung Cancer : A Prospective, Single-arm, Multicenter Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: SCLC
Keywords: SCLC，irinotecan liposome(II)，Ivonescimab
Lead sponsor: The Second Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
Collaborators: name: Shengjing Hospital
First posted: 2025-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Objective response rate（ORR）
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
measure: Treatment related adverse events (TRAEs)
timeFrame: Up to 30 days after last treatment
Other outcomes:
Locations:
city: Dalian
country: China
facility: The Second Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Wei Zheng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Dalian Medical University
name: Zhaoxia Dai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.