SCLC
Conditions
Keywords
SCLC，irinotecan liposome(II)，Ivonescimab
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.
Interventions
DRUGirinotecan 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
Sponsors
Shengjing Hospital
The Second Affiliated Hospital of Dalian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
Countries
China
Contacts
Primary ContactJincheng Song, MD
Outcome results
None listed