A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in 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
NCT07535437
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
    20 mg/kg
  • Dato-DXd — DRUG
    dose escalation 4 mg/kg 6 mg/kg
  • Osimertinib — DRUG
    dose escalation 40mg 80 mg

Study Details

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.

Key Dates

Start date
Apr 9, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (ivonescimab + Dato-DXd) Phase IA
    3 + 3 escalation (2 dose levels)
  • Experimental: Cohort B (Ivonescimab + Osimertinib) Phase IB
    3 + 3 escalation (2 dose levels)
  • Experimental: Cohort A (ivonescimab + Dato-DXd) (Phase II)
    Every 3 weeks
  • Experimental: Cohort B (Ivonescimab + Osimertinib) (Phase II)
    Ivonescimab every 3 weeks + Osimertinib daily

Primary Outcome Measure

determine the maximum tolerated dose (MTD) (phase I) [ Time Frame: 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920
Helena Yu, MD
646-608-3912
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
Helena Yu, MD
646-608-3912
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645
Helena Yu, MD
646-608-3912
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)CommackNew York11725
Helena Yu, MD
646-608-3912
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
Helena Yu, MD
646-608-3912
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Helena Yu, MD
646-608-3912
Gregory Riely, MD, PhD
646-608-3913
Helena Yu, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (All Protocol Activities)UniondaleNew York11553
Helena Yu, MD
646-608-3912

Find similar trials in Basking Ridge, NJ

By condition
Lung cancer
By specialty
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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