Extensive-stage Small-cell Lung Cancer
Conditions
Brief summary
This is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of ivonescimab combined with irinotecan liposome for relapsed small cell lung cancer, who progressed on PD-(L)1 -based first-line therapy.
Detailed description
Patients will receive ivonescimab at 20 mg/kg intravenously, on days 1 of every 21-day cycle and irinotecan liposome 56.5mg/m\^2 intravenously, on days 1 of every 14-day cycle. Treatment will be discontnued in case of the toxicity became intolerable, the investigator determined that there was no further clinical benefit (based on a combination of RECIST 1.1 imaging assessment and clinical status), 24 months of treatment was completed, or the study was withdrawn for other reasons.
Interventions
DRUGivonescimab
20mg/kg, IV, D1, Q3W
56.5mg/m\^2, IV, D1, Q2W
Sponsors
Zhejiang Cancer Hospital
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. 18 to 75 years old (at the time of inform consent obtained). 2. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). 3. Histologically confirmed SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system). 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Life expectancy of at least 3 months. 6. ES-SCLC who failed first-line platinum-based chemotherapy with checkpoint inhibitors. 7. At least one measurable tumor lesion according to RECIST v1.1. 8. Adequate organ function. 9. All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
Exclusion criteria
1. Patients with other cancer in 5 years. 2. Undergone anti-angiogenic therapy prior to the first dose of study treatment. 3. Evidence and history of severe bleeding tendency. 4. History of severe active autoimmune disease that has required systemic treatment in the past 2 years, severe drug allergy or have known allergy to any component of the study drugs. 5. Active central nervous system (CNS) metastases. 6. Active infection requiring systemic therapy. 7. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions. 8. Active hepatitis B/C, or HIV infection. 9. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment. 10. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation. 11. History of alcohol abuse, psychotropic substance abuse or drug abuse. 12. Pregnant or lactating women. 13. Other conditions considered unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month PFS (progression free survival) rate | From the day treatment started to 6 months | PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade 3 or higher adverse events (AEs) | Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years | Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0. |
| Objective response rate (ORR) | Interval between the date of enrollment and the date of death from any cause, up to approximately 2 years | Objective response rate (ORR)is defined as the proportion of subjects with completeresponse(CR)or partial response(PR), based on RECIST v1.1. |
| Disease control rate (DCR) | Interval between the date of enrollment and the date of death due to any cause , up to a maximum of 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. |
| Duration of Response (DOR) | Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years | DOR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first. |
| Progression free survival (PFS) | Interval between the date of enrollment and the date of progressive disease, or death due to any cause (whichever occurs first), up to a maximum of 2 years | PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death due to any cause (whichever occurs first). |
| Overall survival (OS) | Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years | OS is the time from the date of randomization or first dosing date to death due to any cause. |
Countries
China
Outcome results
None listed