A Study of Ivonescimab in First-Line ES-SCLC

Akeso

Status and phase: Enrolling; Phase 2

Conditions: Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Treatments: Drug: Cadonilimab; Drug: Etoposide; Drug: AK117; Drug: Ivonescimab; Drug: Carboplatin (AUC 5)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07245446

AK112-214

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Ivonescimab + AK117 + Chemotherapy

Experimental group

Treatment:

Drug: Carboplatin (AUC 5)

Drug: Ivonescimab

Drug: AK117

Drug: Etoposide

Ivonescimab + Cadonilimab + Chemotherapy

Experimental group

Treatment:

Drug: Carboplatin (AUC 5)

Drug: Ivonescimab

Drug: Etoposide

Drug: Cadonilimab

Ivonescimab + Chemotherapy

Experimental group

Treatment:

Drug: Carboplatin (AUC 5)

Drug: Ivonescimab

Drug: Etoposide