A Study of Ivonescimab in First-Line ES-SCLC
A Phase II Clinical Study of Ivonescimab Combination Therapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
1 other identifier
interventional
180
1 country
3
Brief Summary
The goal of this clinical trial is to learn if different combinations of a drug called Ivonescimab, along with chemotherapy and other investigational drugs, are safe and effective for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). The main questions the study aims to answer are:
- What side effects do participants experience from these combination treatments?
- How well do the treatments work to shrink tumors? Researchers will compare three groups to see which combination works best. All participants will receive Ivonescimab and chemotherapy (etoposide and carboplatin). The differences are:
- Group 1 will also receive an additional drug called AK117.
- Group 2 will also receive a different additional drug called Cadonilimab.
- Group 3 will receive Ivonescimab and chemotherapy only. Participants will:
- Be assigned by chance to one of the three groups.
- Undergo an initial treatment phase (about 3 months), receiving chemotherapy plus the specific study drugs for their group.
- If the treatment is effective and side effects are manageable, continue with a maintenance phase using only the study drugs (without chemotherapy) for up to 2 years.
- Attend regular clinic visits for check-ups, blood tests, and imaging scans (like CT scans) to see how they are responding to the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2025
CompletedStudy Start
First participant enrolled
October 29, 2025
CompletedFirst Posted
Study publicly available on registry
November 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
November 24, 2025
November 1, 2025
2.1 years
September 29, 2025
November 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Objective Response Rate (ORR)
The proportion of participants achieving a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Up to approximately 2 years.
Incidence of Adverse Events (AEs)
The number and percentage of participants experiencing any Adverse Event (AE). An AE is defined as any untoward medical occurrence in a participant administered a study drug, which may not have a causal relationship with the treatment. Severity will be graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
From first dose up to 90 days after last dose.
Secondary Outcomes (7)
Disease Control Rate (DCR)
Up to approximately 2 years.
Duration of Response (DoR)
Up to approximately 2 years.
Time to Response (TTR)
Up to approximately 2 years.
Progression-Free Survival (PFS)
Up to approximately 2 years.
Overall Survival (OS)
Up to approximately 5 years.
- +2 more secondary outcomes
Study Arms (3)
Ivonescimab + AK117 + Chemotherapy
EXPERIMENTALIvonescimab + Cadonilimab + Chemotherapy
EXPERIMENTALIvonescimab + Chemotherapy
EXPERIMENTALInterventions
Administered intravenously at a specified dose and frequency.
Administered intravenously at a specified dose and frequency.
Administered intravenously at a specified dose and frequency.
Administered intravenously at 100 mg/m² on Days 1-3 of each 3-week cycle for 4 cycles.
Administered intravenously at AUC 5 on Day 1 of each 3-week cycle for 4 cycles.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- No prior systemic therapy for ES-SCLC.
- At least one measurable lesion as defined by RECIST v1.1.
- Age 18 to 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
You may not qualify if:
- Active or untreated central nervous system (CNS) metastases (Treated, stable brain metastases are allowed).
- History of severe hypersensitivity to monoclonal antibodies.
- Active autoimmune disease requiring systemic treatment within the past 2 years.
- Significant cardiovascular disease.
- Active hepatitis B or C, or HIV infection.
- Interstitial lung disease or non-infectious pneumonitis.
- Significant bleeding tendency or risk, including tumor invasion of major blood vessels.
- Pregnancy or lactation.
- Other active malignancies within 5 years prior to enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Akesolead
Study Sites (3)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100020, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000, China
Shanghai Pulmonary Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, 200433, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2025
First Posted
November 24, 2025
Study Start
October 29, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
November 24, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share