NCT07245446RecruitingPhase 2

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)

Source: ClinicalTrials.gov · Last updated 24 Nov 2025

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 180 (estimated)
First submitted: 29 Sept 2025
Start date: Oct 2025
Primary completion date: Dec 2027
Lead sponsor: Akeso
Diseases: Lung cancer
NCT number: NCT07245446

What you commit to

Study type: Interventional · Phase 2
Planned participants: 180
From Oct 2025 to the primary completion date, Dec 2027
3 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Other active malignancies within 5 years prior to enrollment.

Other illness

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.

Other

Active or untreated central nervous system (CNS) metastases (Treated, stable brain metastases are allowed).
Pregnancy or lactation.

Who the study is looking for

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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status	Beijing	China	Not yet recruiting
Shanghai Pulmonary Hospital Affiliated to Tongji University Coordinator of this site? Confirm its status	Shanghai	China	Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status	Xi’an	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.