A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for ES-SCLC

Phase 2Not Yet RecruitingNCT06478043

Zhejiang Cancer Hospital54 enrolled

Overview

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.

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of RECIST V1.1 imaging assessment and clinical status), 24 months of treatment was completed, or the study was withdrawn for other reasons.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Extensive-stage Small-cell Lung Cancer

Interventions

ivonescimabDRUG

20mg/kg, IV, D1, Q3W

irinotecan liposomeDRUG

56.5mg/m\^2, IV, D1, Q2W

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Objective response rate（ORR）

Objective response rate (ORR) is defined as the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

Time frame: Interval between the date of enrollment and the date of death from any cause, up to approximately 2 years

Secondary Outcomes

Incidence of Grade 3 or higher adverse events (AEs)

Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0.

Time frame: Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years

Disease control rate (DCR)

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.

Time frame: Interval between the date of enrollment and the date of death due to any cause , up to a maximum of approximately 2 years

Duration of Response (DOR)

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.

Time frame: Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years

Progression free survival (PFS)

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).

Time frame: 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

Data from ClinicalTrials.gov

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