Actively Recruiting
A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-21
66
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 find out whether ivonescimab in combination with datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. The researchers will test different doses of the Dato-DXd or osimertinib with an unchanging (fixed) dose of ivonescimab to find the best dose that causes few or mild side effects in participants. Once the dose is found the researchers will test ivonescimab with Dato-DXd or osimertinib in a new group of participants to see if it is effective in treating their NSCLC with an EGFR mutation.
CONDITIONS
Official Title
A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent by participant
- Biopsy-proven metastatic non-small cell lung cancer
- Somatic activating mutation in EGFR in pre-treatment tumor biopsy or cfDNA by any CLIA certified assay
- Prior treatment with 3rd-generation EGFR TKI therapy and platinum-based chemotherapy (or ineligible for platinum-based chemotherapy)
- At least one measurable (RECIST 1.1) indicator lesion not previously irradiated
- ECOG performance status 0-1
- Age 18 years or older
- Ability to swallow oral medications (Study Cohort B only)
- Adequate organ function including specific liver enzymes, bilirubin, kidney function, urine protein, neutrophil count, hemoglobin, platelets, and coagulation parameters
- Negative pregnancy test for females of childbearing age on dosing day
- Agreement to use highly effective contraception by females of childbearing potential and unsterilized males with partners of childbearing potential during and after treatment
You will not qualify if you...
- EGFR exon 20 insertion positive lung cancer with expected lack of sensitivity to osimertinib (Study Cohort B only)
- Pregnant or lactating women
- Participation in another clinical study with investigational treatment within last 4 weeks
- Prior exposure to anti-PD-1 inhibitor therapy
- Prior exposure to ADC containing topoisomerase I or TROP2 antibody (Study Cohort A only)
- History of clinically significant corneal disease (Study Cohort A only)
- Poorly controlled hypertension despite oral therapy
- Major surgery or serious trauma within 4 weeks before enrollment or planned within 4 weeks after first dose
- History of bleeding tendencies or recent significant bleeding
- Active or prior autoimmune or inflammatory disorders requiring systemic therapy with exceptions
- History of major cardiovascular or gastrointestinal diseases within specified time frames
- Imaging showing major blood vessel invasion or tumor invading critical organs increasing bleeding risk
- History of another primary malignancy except certain treated cancers without active disease
- Symptomatic or recently treated CNS metastases
- Recent live vaccine administration or planned live vaccine during study
- Severe infection within 4 weeks prior to first dose
- Pre-existing Grade 2 or higher peripheral neuropathy
- Uncontrolled pleural, pericardial effusions, or ascites with exceptions
- History of interstitial lung disease requiring steroids
- Current systemic corticosteroid use above specified dose
- Uncontrolled HIV infection
- History of allogeneic organ or stem cell transplantation
- Active hepatitis B or C with unstable or untreated viral load
- Known allergy or severe hypersensitivity to study drugs
- Any medical, surgical, psychiatric, or laboratory condition that may interfere with study participation or safety as judged by investigator
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)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
H
Helena Yu, MD
CONTACT
G
Gregory Riely, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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