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NCT Number: NCT07245446

A Study of Ivonescimab in First-Line ES-SCLC

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.

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Key information

Conditions

Extensive-stage Small Cell Lung Cancer (ES-SCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years.

    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.

  2. Incidence of Adverse Events (AEs)

    Time frame: From first dose up to 90 days after last dose.

    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.

Secondary outcomes

  1. Disease Control Rate (DCR)

    Time frame: Up to approximately 2 years.

    The proportion of participants achieving a BOR of CR, PR, or Stable Disease (SD), as assessed by the investigator per RECIST v1.1.

  2. Duration of Response (DoR)

    Time frame: Up to approximately 2 years.

    For responders (participants achieving CR or PR), DoR is defined as the time from the first documented evidence of CR or PR until the first documented disease progression or death from any cause, whichever occurs first, per RECIST v1.1.

  3. Time to Response (TTR)

    Time frame: Up to approximately 2 years.

    For responders (participants achieving CR or PR), TTR is defined as the time from the start of study treatment to the first documented objective response (CR or PR), per RECIST v1.1.

  4. Progression-Free Survival (PFS)

    Time frame: Up to approximately 2 years.

    PFS is defined as the time from the start of study treatment to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.

  5. Overall Survival (OS)

    Time frame: Up to approximately 5 years.

    OS is defined as the time from the start of study treatment to death from any cause.

  6. Serum concentrations of Ivonescimab, Cadonilimab, and AK117

    Time frame: Up to approximately 2 years.

    Serum concentrations of Ivonescimab, Cadonilimab, and AK117 will be measured to characterize the pharmacokinetic (PK) profiles.

  7. Incidence of Anti-drug Antibodies (ADA)

    Time frame: Up to approximately 2 years.

    The immunogenicity will be assessed by the incidence of participants who develop detectable anti-drug antibodies (ADA) against Ivonescimab, Cadonilimab, and/or AK117.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenting Li

CONTACT

[email protected]

+86-18116403289

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

A Phase II Clinical Study of Ivonescimab Combination Therapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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