A Study of Ivonescimab in First-Line ES-SCLC

Sponsor
Akeso
Study ID
NCT07245446
Phase
PHASE2
Status
Recruiting
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Conditions

  • Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab — DRUG
    Administered intravenously at a specified dose and frequency.
  • Cadonilimab — DRUG
    Administered intravenously at a specified dose and frequency.
  • AK117 — DRUG
    Administered intravenously at a specified dose and frequency.
  • Etoposide — DRUG
    Administered intravenously at 100 mg/m² on Days 1-3 of each 3-week cycle for 4 cycles.
  • Carboplatin (AUC 5) — DRUG
    Administered intravenously at AUC 5 on Day 1 of each 3-week cycle for 4 cycles.

Study Details

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.

Key Dates

Start date
Oct 29, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ivonescimab + AK117 + Chemotherapy
  • Experimental: Ivonescimab + Cadonilimab + Chemotherapy
  • Experimental: Ivonescimab + Chemotherapy

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years. ]

Central Contacts

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