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

NCT ID: NCT06820762

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2027-12-31

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.

Conditions

SCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Drug: ivonescimab 20mg/kg, IV, D1, Q3W

Other Names:

AK112 Drug: irinotecan liposome(II) 70mg/m^2, IV, D1, Q3W

Interventions

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Zheng, MD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Zhaoxia Dai, MD

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Dalian Medical University

Locations

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Countries

China

Central Contacts

Jincheng Song, MD

Role: CONTACT

wwepqwq@163.com

0411-84671291-6152

Facility Contacts

Role: primary

0411-84671291-6152

Wei Zheng

Role: primary

024-96615-63211

References

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.

Reference Type: BACKGROUND

PMID: 38648575 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39490738 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36147357 (View on PubMed)

Other Identifiers

HR070803-SCLC

Identifier Type: -

Identifier Source: org_study_id