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

Launched by THE SECOND AFFILIATED HOSPITAL OF DALIAN MEDICAL UNIVERSITY · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for small cell lung cancer (SCLC) using a combination of two drugs: irinotecan liposome(II) and Ivonescimab. This study is designed for patients whose first treatment with chemotherapy hasn't worked. The aim is to see if this new combination can help improve their condition and how safe it is to use. The trial is in its second phase and is not yet recruiting participants.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of advanced SCLC that did not respond to previous chemotherapy. They should also be in relatively good health, with a reasonable life expectancy. Participants will need to have at least one tumor that can be measured for the study's assessment. Women must have a negative pregnancy test and agree to use effective contraception during the trial. If you or a loved one are considering this trial, it's essential to discuss it with your healthcare provider to see if it might be a suitable option.

Gender

ALL

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.