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

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

This test tries whether adding AK117 or cadonilimab to ivonescimab plus chemotherapy helps adults newly diagnosed with extensive-stage small cell lung cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Akeso (Industry-sponsored)
• Drugs / interventions: Ivonescimab, Cadonilimab, chemotherapy
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT07245446 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with newly diagnosed, measurable extensive‑stage small cell lung cancer, ECOG 0–1, no prior systemic therapy for ES‑SCLC, and adequate organ function.

Not a fit: Patients with active untreated brain metastases, active hepatitis B/C or HIV, recent systemic autoimmune treatment, significant cardiovascular or lung disease, pregnancy, or recent other malignancies are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, one of the combinations could produce higher tumor shrinkage or longer survival as a safer first‑line option for ES‑SCLC.

How similar studies have performed: Adding immune checkpoint inhibitors to chemotherapy has improved outcomes in first‑line ES‑SCLC in prior trials, but the specific antibody combinations tested here are investigational and not yet proven.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 2 other locations

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• 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)

Study contacts

• Study coordinator: Wenting Li

Conditions Extensive-stage Small Cell Lung Cancer