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Trial Title:
A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for ES-SCLC
NCT ID:
NCT06478043
Condition:
Extensive-stage Small-cell Lung Cancer
Conditions: Official terms:
Small Cell Lung Carcinoma
Irinotecan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ivonescimab
Description:
20mg/kg, IV, D1, Q3W
Arm group label:
ivonescimab and irinotecan liposome
Other name:
AK112
Intervention type:
Drug
Intervention name:
irinotecan liposome
Description:
56.5mg/m^2, IV, D1, Q2W
Arm group label:
ivonescimab and irinotecan liposome
Other name:
Irinotecan liposome injection
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treatment was completed, or the study was withdrawn for other reasons.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Contact:
Last name:
Yun Fan, MD
Investigator:
Last name:
Yun Fan, MD
Email:
Principal Investigator
Start date:
September 1, 2024
Completion date:
September 1, 2027
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06478043
