Actively Recruiting
Phase II Study of Platinum/Etoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer
Led by PrECOG, LLC. · Updated on 2026-05-14
60
Participants Needed
6
Research Sites
196 weeks
Total Duration
On this page
Sponsors
P
PrECOG, LLC.
Lead Sponsor
S
Summit Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Eligible untreated participants with Extensive Stage Small Cell Lung Cancer (ES-SCLC) who are ≥ 18 years of age will be randomized to receive ivonescimab 10 milligrams per kilogram (mg/kg) or ivonescimab 20 mg/kg in combination with carboplatin and etoposide. Ivonescimab is a type of drug called a bispecific antibody. Antibodies are proteins that specifically recognize and bind to other types of proteins called antigens. Antibodies and antigens can work together to help the immune system fight cancer cells. Bispecific antibody, meaning it targets two different molecules at the same time. Ivonescimab is a new drug that may help the immune system attack cancer cells and may also block certain pathways that cancer uses to grow and spread. This dual action of ivonescimab aims to help the immune system to fight the cancer and also disrupt tumor growth by blocking blood vessel formation that tumors use to grow. Participants will receive induction with 4 cycles of ivonescimab (dose determined by randomization) with standard of care carboplatin and etoposide followed by maintenance therapy with ivonescimab at the same dose received during induction. Treatment will continue until disease progression, unacceptable toxicity or participant withdrawal. The purpose of this study is to determine what dose of ivonescimab works best in combination with carboplatin and etoposide chemotherapy in ES-SCLC. We will also examine the side effects, good and bad, associated with ivonescimab.
CONDITIONS
Official Title
Phase II Study of Platinum/Etoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have pathologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC).
- Patients must be 18 years of age or older.
- No prior systemic therapy for ES-SCLC.
- Measurable disease according to RECIST v1.1.
- ECOG performance status of 0 or 1.
- Ability to understand and sign informed consent.
- Willingness to provide archived tumor tissue and blood samples if available.
- Adequate organ and marrow function within 14 days prior to registration, including ANC 60; 1500/mcL, platelets 60; 100,000/mcL, hemoglobin >9.0 g/dL, PT/INR 60; 1.5x ULN, PTT/aPTT 60; 1.5x ULN, serum creatinine 60; 2x ULN, creatinine clearance 60; 50 mL/min, urine protein <2+, ALT and AST 60; 2.5x ULN (or 60; 5x ULN with liver metastasis), total bilirubin 60; 1.5x ULN (or 60; 3x ULN with liver metastasis or Gilbert's disease).
- Not pregnant or breast-feeding.
- Use of effective contraception or abstinence during study and for 120 days after last dose.
You will not qualify if you...
- Symptomatic central nervous system (CNS) metastases or CNS metastasis 60; 1.5 cm.
- CNS radiation within 7 days prior to randomization or planned during first cycle.
- Leptomeningeal disease.
- Radiological evidence of major blood vessel invasion or tumor invading critical organs with risk of fistula.
- Major blood vessel encasement with vessel narrowing or lung cavitation posing bleeding risk.
- Prior or concurrent malignancy interfering with safety or efficacy assessment.
- Major surgery or serious trauma within 28 days before randomization or planned within 28 days after first dose.
- History of bleeding disorders or clinically significant bleeding within 4 weeks before randomization.
- Use of unstable anticoagulants or antiplatelet agents prior to randomization.
- History of serious cardiac conditions or vascular disease requiring hospitalization within 12 months.
- History of arterial or severe venous thromboembolic events within 12 months.
- History of severe gastrointestinal conditions or recent major GI surgery within 6 months.
- Poorly controlled hypertension despite therapy.
- Prolonged QTc interval >480 msec.
- Active autoimmune or lung disease requiring systemic therapy within 2 years.
- Severe infection or active infection requiring systemic therapy within 4 weeks or 2 weeks, respectively.
- Uncontrolled pleural, pericardial effusions, or ascites causing symptoms.
- History of non-infectious pneumonia requiring corticosteroids or current interstitial lung disease.
- Active or prior inflammatory bowel disease.
- Pre-existing peripheral neuropathy grade 2 or higher.
- Recent live vaccine within 28 days.
- Allergy to study drugs or excipients.
- Serious medical or psychiatric illness interfering with protocol.
- Participation in other therapeutic clinical trials without prior approval.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
2
Montefiore Medical Center- Montefiore Medical Park
The Bronx, New York, United States, 10461
Actively Recruiting
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
4
Guthrie
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
5
Universtiy of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
6
Aspirus Cancer Center Wausau
Wausau, Wisconsin, United States, 54401
Actively Recruiting
Research Team
R
Rucha Shah, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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