Actively Recruiting
A Study of Ivonescimab, Chemotherapy, and Stereotactic Radiosurgery for People With Non-Small Cell Lung Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-17
53
Participants Needed
7
Research Sites
103 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
S
Summit Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
The researchers are doing this study to test the safety of ivonescimab given in combination with standard chemotherapy and stereotactic radiosurgery (SRS) in people with non-small cell lung cancer (NSCLC) that has spread to the brain (brain metastases). The researchers will test different doses of the study drug to find the best dose that causes few or mild side effects in participants. Once the dose is found, the researchers will test it in a new group of participants to see if it is effective in treating their NSCLC brain metastases.
CONDITIONS
Official Title
A Study of Ivonescimab, Chemotherapy, and Stereotactic Radiosurgery for People With Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed non-small cell lung cancer, including squamous and non-squamous types
- At least one brain metastasis measuring 1.0 cm to 3.5 cm, safe for stereotactic radiosurgery
- PD-L1 tumor proportion score available
- ECOG performance status of 0 or 1
- Age 18 years or older
- Expected life expectancy greater than 3 months
- Able to provide written informed consent or have a legally authorized representative do so
- Willing to comply with all study requirements
- Adequate blood counts, kidney, liver, and coagulation function as specified
- Resolution of prior therapy toxicities to baseline or Grade 1 (with some exceptions)
- Steroid use limited to dexamethasone 4 mg or less daily for at least one week before enrollment
- Use of effective contraception for females of childbearing potential and male participants with partners of childbearing potential during treatment and for 90 days after last dose
You will not qualify if you...
- Small cell lung cancer diagnosis
- Previous stereotactic radiosurgery retreatment of the same brain metastasis
- Unable to have contrast-enhanced brain MRI
- Brainstem metastasis 1.0 cm or larger
- Leptomeningeal disease
- Previous immunotherapy treatment (exceptions apply)
- Recent or planned major surgery
- History of bleeding disorders or significant bleeding risk
- Poorly controlled high blood pressure
- Active autoimmune or lung disease requiring systemic therapy within 2 years
- Serious heart conditions or recent cardiovascular events
- Recent gastrointestinal complications or bleeding
- Major blood vessel invasion or tumor encasement increasing bleeding risk
- Intracranial hemorrhage history or brain metastasis with hemorrhage component
- Recent live vaccine use
- Severe infection within 4 weeks before enrollment
- Moderate to severe peripheral neuropathy
- Uncontrolled fluid buildup such as pleural or pericardial effusions
- Non-infectious pneumonia requiring steroids or interstitial lung disease
- Active or prior inflammatory bowel disease
- Uncontrolled HIV infection
- History of organ or stem cell transplantation
- Active hepatitis B or untreated hepatitis C
- Allergies to study drugs or severe antibody hypersensitivity
- Any condition that may interfere with study participation or increase risk
- Currently breastfeeding or planning to breastfeed during the study
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
L
Luke Pike, MD, PhD
CONTACT
M
Mark Awad, M.D., PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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