A Study of Ivonescimab, Chemotherapy, and Stereotactic Radiosurgery for People With Non-Small Cell Lung Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07535463
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab — DRUG
    Ivonescimab will be administered IV on Day 1 of the first cycle starting at 10 mg/kg with chemotherapy. Dose escalation will proceed to 15 mg/kg and 20 mg/kg as tolerated.
  • Stereotactic Radiosurgery — RADIATION
    (9Gy x 3 fractions) starting on Days 7-10.

Study Details

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.

Key Dates

Start date
Apr 10, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
53 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ivonescimab, Chemotherapy, and Stereotactic Radiosurgery
    In the Phase I portion of the study, patients with NSCLC brain metastases will receive ivonescimab at a starting dose of 10 mg/kg on Day 1 (with chemotherapy), followed by stereotactic radiosurgery (9Gy x 3 fractions) starting on Days 7-10. Following a toxicity check at Day 21, patients will receive standard dosing of ivonescimab with chemotherapy at the discretion of the medical oncologist. In the Phase II portion of the study, patients will receive the RP2D from the initial phase of ivonescimab and chemotherapy on C1D1, followed by stereotactic radiosurgery (9Gy x 3 fractions) starting on Days 7-10.

Primary Outcome Measure

identify the Recommended Phase 2 Dose (RPD2) [ Time Frame: 21 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920
Luke Pike, MD, PhD
212-639-8157
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
Luke Pike, MD, PhD
212-639-8157
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645
Luke Pike, MD, PhD
212-639-8157
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)CommackNew York11725
Luke Pike, MD, PhD
212-639-8157
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
Luke Pike, MD, PhD
212-639-8157
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Luke Pike, MD, PhD
212-639-8157
Memorial Sloan Kettering Nassau (All Protocol Activities)Rockville CentreNew York11553
Luke Pike, MD, PhD
212-639-8157

Find similar trials in Basking Ridge, NJ

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Lung cancer
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OncologyLung oncologyLung disease
By research site
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (All Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (All Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (All Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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