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

NCT06478043 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: IRB-2024-543 (IIT)
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Extensive-stage Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

• Overall survival (OS)

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

Study Arms (1)

ivonescimab and irinotecan liposome

EXPERIMENTAL

Subjects receive ivonescimab plus irinotecan liposome until progression.

Drug: ivonescimab; Drug: irinotecan liposome

Interventions

ivonescimab DRUG

20mg/kg, IV, D1, Q3W

Also known as: AK112

ivonescimab and irinotecan liposome

irinotecan liposome DRUG

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

Also known as: Irinotecan liposome injection

ivonescimab and irinotecan liposome

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years old (at the time of inform consent obtained).
• Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
• Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least 3 months.
• ES-SCLC who failed first-line platinum-based chemotherapy with checkpoint inhibitors.
• At least one measurable tumor lesion according to RECIST v1.1.
• Adequate organ function.
• 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.

You may not qualify if:

• Patients with other cancer in 5 years.
• Undergone anti-angiogenic therapy prior to the first dose of study treatment.
• Evidence and history of severe bleeding tendency.
• 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.
• Active central nervous system (CNS) metastases.
• Active infection requiring systemic therapy.
• Current presence of uncontrolled pleural, pericardial, and peritoneal effusions.
• Active hepatitis B/C, or HIV infection.
• History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment.
• History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation.
• History of alcohol abuse, psychotropic substance abuse or drug abuse.
• Pregnant or lactating women.
• Other conditions considered unsuitable for this study by the investigator.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

irinotecan sucrosofate

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)