Ivonescimab combinations for first-line extensive-stage small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 trial enrolls adults with treatment‑naïve ES‑SCLC and compares three first‑line regimens: ivonescimab plus etoposide and carboplatin with either AK117, cadonilimab, or no additional antibody. All participants receive the same chemotherapy backbone and ivonescimab, are assigned by chance to a group, and undergo an initial induction period of about three months with response measured by RECIST v1.1. The study tracks safety and side effects closely in addition to tumor shrinkage and other efficacy measures. Sites are located at major cancer centers in Beijing, Xi'an, and Shanghai, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Xi'an Jiaotong University
  Xi'an, Shaanxi, China Recruiting
• Shanghai Pulmonary Hospital Affiliated to Tongji University
  Shanghai, Shanghai Municipality, China Recruiting
• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Wenting Li
• Email: wenting01.li@akesobio.com
• Phone: +86-18116403289

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.