Ivonescimab for Small Cell Lung Cancer
(PrE0510 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the most effective dose of a new drug, ivonescimab, when combined with standard chemotherapy drugs carboplatin and etoposide for treating Extensive Stage Small Cell Lung Cancer (ES-SCLC). Ivonescimab is a bispecific antibody that targets two different molecules to help the immune system fight cancer and block tumor growth. Participants will receive either a 10 mg/kg or 20 mg/kg dose of ivonescimab, along with chemotherapy, while researchers study the treatment's effects and any side effects. This trial seeks individuals diagnosed with ES-SCLC who have not yet received any systemic treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ivonescimab, when combined with the chemotherapy drugs carboplatin and etoposide, is generally well tolerated by patients. In studies, this combination has produced promising results in treating extensive-stage small cell lung cancer (ES-SCLC). Participants did not experience severe side effects that were unexpected or unusual for cancer treatments. This suggests that ivonescimab, along with these chemotherapy drugs, has a safety profile that patients managed well.
For those considering joining a trial, it's important to know that previous patients found the treatment manageable. While every treatment carries potential risks, current data indicates that ivonescimab is a promising and safe option for people with ES-SCLC.12345Why are researchers excited about this study treatment for small cell lung cancer?
Researchers are excited about ivonescimab for small cell lung cancer because it brings a fresh approach to treatment. Traditional options usually involve chemotherapy drugs like carboplatin and etoposide. However, ivonescimab is an innovative antibody that targets specific proteins involved in tumor growth, potentially offering a more precise attack on cancer cells. Unlike the standard chemotherapy, ivonescimab's targeted mechanism might improve effectiveness and reduce side effects, making it a promising candidate for patients who haven't responded well to existing treatments.
What evidence suggests that ivonescimab could be an effective treatment for small cell lung cancer?
Research has shown that ivonescimab, combined with etoposide and carboplatin, shows promise in treating extensive-stage small cell lung cancer (ES-SCLC). This trial will test two dosages of ivonescimab: one group will receive 10 mg/kg, and another will receive 20 mg/kg. Patients have tolerated this combination well, as it does not cause severe side effects. Studies also highlight that ivonescimab can extend the time patients live without their cancer worsening. Ivonescimab is a unique antibody that targets two molecules simultaneously, aiding the immune system in fighting cancer and blocking the pathways tumors use to grow. These findings suggest ivonescimab could effectively treat ES-SCLC.16789
Who Is on the Research Team?
Taofeek Owonikoko, MD, PhD
Principal Investigator
University of Maryland, Baltimore
Are You a Good Fit for This Trial?
Adults (≥18 years) with untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC), measurable disease, and good performance status. They must have normal blood counts, organ function, and be willing to provide tissue samples. Those who've had prior systemic therapy for ES-SCLC or don't meet health criteria can't participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive induction treatment with ivonescimab, carboplatin, and etoposide every 21 days for 4 cycles
Maintenance Therapy
Participants continue maintenance therapy with ivonescimab every 21 days at the dose received during induction until disease progression, unacceptable toxicity, or participant withdrawal
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ivonescimab
Trial Overview
The trial is testing two doses of Ivonescimab (10 mg/kg or 20 mg/kg) combined with chemotherapy drugs carboplatin and etoposide in patients with ES-SCLC. It aims to find the best dose for effectiveness and safety during induction and maintenance phases until disease progression or side effects occur.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Induction with ivonescimab 20 mg/kg, carboplatin and etoposide every 21 days x 4 cycles followed by maintenance ivonescimab 20 mg/kg every 21 days until progression, unacceptable toxicity or participant withdrawal. Up to 24 months of ivonescimab from cycle 1 day 1 of Induction.
Induction with ivonescimab 10 mg/kg, carboplatin and etoposide every 21 days x 4 cycles followed by maintenance ivonescimab 10 mg/kg every 21 days until progression, unacceptable toxicity or participant withdrawal. Up to 24 months of ivonescimab from cycle 1 day 1 of Induction.
Find a Clinic Near You
Who Is Running the Clinical Trial?
PrECOG, LLC.
Lead Sponsor
Summit Therapeutics
Industry Sponsor
Citations
Ivonescimab Combined With Etoposide Plus Carboplatin ...
Ivonescimab in combination with etoposide and carboplatin was well tolerated and found to have promising antitumor activity in extensive-stage SCLC.
A Study of Ivonescimab in First-Line ES-SCLC
The goal of this clinical trial is to learn if different combinations of a drug called Ivonescimab, along with chemotherapy and other ...
3.
medicine.yale.edu
medicine.yale.edu/publication-details/ivonescimab-enhances-survival-in-lung-cancer-patients/Ivonescimab Shows Promise in Enhancing Survival in Lung ...
This study investigates ivonescimab's significant progression-free survival improvement over pembrolizumab in advanced-stage NSCLC, ...
HARMONi-2 Ivonescimab Outperforms Pembrolizumab as ...
Ivonescimab was compared with the PD-1 inhibitor pembrolizumab as first-line treatment of PD-L1–positive advanced non–small cell lung cancer (NSCLC).
Brief Report: Ivonescimab Combined With Etoposide Plus ...
Ivonescimab in combination with etoposide and carboplatin was well tolerated and found to have promising antitumor activity in extensive-stage SCLC.
Phase II Study of Platinum/Etoposide Plus Ivonescimab for ...
Patients must have pathologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC). No prior systemic therapy for the disease under study (ES-SCLC).
Brief Report: Ivonescimab Combined With Etoposide Plus ...
Ivonescimab in combination with etoposide and carboplatin was well tolerated and found to have promising antitumor activity in extensive-stage ...
Ivonescimab in Combination with Chemotherapy ...
In patients with up to 63% central squamous carcinoma, ivonescimab demonstrated a safety profile comparable to the control group. This ...
Efficacy and Safety of Ivonescimab in the Treatment of ... - PMC
Ivonescimab showed promising antitumor activity and improved clinical outcomes, particularly in patients with higher PD-L1 expression levels and those ...
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