Clinical trial NCT06478043: A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for ES-SCLC
Official title: Phase II Study of AK112 Combined With Irinotecan Liposome in Patients With ES-SCLC Who Progressed on Immune Checkpoint Inhibitors and Chemotherapy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Extensive-stage Small-cell Lung Cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 54
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 is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of ivonescimab combined with irinotecan liposome for relapsed extensive stage small cell lung cancer, who progressed on PD-(L)1 -based first-line therapy.

Detailed description: Patients will receive ivonescimab at 20mg/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 until the toxicity became intolerable, the investigator determined that there was no further clinical benefit (based on a combination of RECIST V1.1 imaging assessment and clinical status), 24 months of treatment was completed, or the study was withdrawn for other reasons.

Eligibility criteria: 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 or cytologically confirmed ES-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.

Primary outcomes:
measure: Objective response rate（ORR）
timeFrame: Interval between the date of enrollment and the date of death from any cause, up to approximately 2 years
Secondary outcomes:
measure: Incidence of Grade 3 or higher adverse events (AEs)
timeFrame: Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years
measure: Disease control rate (DCR)
timeFrame: Interval between the date of enrollment and the date of death due to any cause , up to a maximum of approximately 2 years
measure: Duration of Response (DOR)
timeFrame: Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years
measure: Progression free survival (PFS)
timeFrame: 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
measure: Overall survival (OS)
timeFrame: Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: