Phase II Study of Ivonescimab for Extensive-Stage Small Cell Lung Cancer
This study is testing two different doses of a new drug called ivonescimab, combined with standard chemotherapy (carboplatin and etoposide), for people with extensive-stage small cell lung cancer (ES-SCLC). Ivonescimab is a bispecific antibody, meaning it's a special protein designed to help your immune system fight cancer cells by targeting two different molecules at once. The study aims to find the best dose of ivonescimab that is both effective and safe. You could be eligible if you have ES-SCLC that hasn't been treated with other systemic therapies, are at least 18 years old, and have measurable disease. The study will measure how many people respond to the treatment and the rate of serious side effects over 18 months. The current recruitment status is unclear.
- Study design
- This is a randomized, open-label Phase II study involving 60 participants. Participants will be randomly assigned to receive one of two doses of ivonescimab.
- What's involved
- You will receive ivonescimab, carboplatin, and etoposide for four cycles (each 21 days long), followed by maintenance ivonescimab every 21 days until your disease progresses or you withdraw. Tumor tissue will be requested at the beginning of the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main study outcomes, including response rate and serious side effects, will be measured at 18 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase II Study of Platinum/Etoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer
At a glance
Conditions
Where it's being run
13 sites across 9 statesStudy leadership
- Taofeek Owonikoko, MD, PhD · STUDY_CHAIR · University of Maryland, Baltimore
Who to contact
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What this trial measures
- Optimal Dose of Ivonescimab in Combination with Carboplatin and Etoposide - Overall Response Rate (ORR)18 months
Overall Response Rate (ORR) defined as the proportion of participants achieving complete response (CR) or partial response (PR) as best response on treatment based on RECIST v1.1 criteria at each dose level.
- Optimal Dose of Ivonescimab in Combination with Carboplatin and Etoposide - Grade 3-5 Treatment-Related Toxicity Rate18 months
All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE V5.0) that are not resolved in accordance with treatment guidelines will be counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.