A Study of Tepotinib and Ivonescimab 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
NCT07619339
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Tepotinib — DRUG
    Tepotinib will be administered at 225mg or 450mg oral daily continuously in every 3 week cycles.
  • Ivonescimab — DRUG
    Ivonescimab is administered IV Q3W on Day 1 of each cycle. The total duration of ivonescimab treatment is up to 24 months.

Study Details

The researchers are doing this study to find out whether the combination of tepotinib and ivonescimab is a safe and effective treatment for people with non-small cell lung cancer (NSCLC) that is positive for METex14 skipping. The researchers will test up to two different doses of tepotinib in combination with ivonescimab to find the best dose of tepotinib that causes few or mild side effects in participants.

Key Dates

Start date
May 27, 2026
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

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

Arms

  • Experimental: Tepotinib and Ivonescimab
    The study is divided into an initial dose finding phase and subsequent dose expansion phase. A total of 16 patients will be enrolled across these two phases. The sample size for this study was not based on formal power calculations for efficacy, instead focusing on the qualitative description of safety for the combination of tepotinib + ivonescimab.

Primary Outcome Measure

Dose finding [ Time Frame: 2 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920
Paul Paik, MD
646-608-3759
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
Paul Paik, MD
646-608-3759
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645
Paul Paik, MD
646-608-3759
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )CommackNew York11725
Paul Paik, MD
646-608-3759
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
Paul Paik, MD
646-608-3759
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Paul Paik, MD
646-608-3759
Memorial Sloan Kettering Nassau (All Protocol Activities)UniondaleNew York11553
Paul Paik, MD
646-608-3759

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