A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)

Part of paid clinical trials in Clermont, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07286149
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Lung Neoplasm Malignant

Eligibility Criteria

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

Interventions

  • MK-1084 — DRUG
    Oral administration
  • Patritumab deruxtecan — BIOLOGICAL
    IV infusion
  • Sacituzumab tirumotecan — BIOLOGICAL
    IV Infusion
  • Cetuximab — BIOLOGICAL
    IV Infusion
  • Rescue Medications — DRUG
    Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent) for prevention of chemotherapy induced nausea and vomiting.

Study Details

Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn: * About the safety of MK-1084 and if people tolerate it when taken with other treatments * How many people have the cancer respond (get smaller or go away) to the treatments

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Aug 11, 2031
Completion
May 6, 2037

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: MK-1084 + Patritumab deruxtecan (HER3-DXd)
    Participants will receive MK-1084 and HER3-DXd until discontinuation due to toxicity, adverse event (AE) or at the discretion of an investigator.
  • Experimental: MK-1084 + Sacituzumab tirumotecan (Sac-TMT)
    Participants will receive MK-1084 and sac-TMT until discontinuation due to toxicity, AE or at the discretion of an investigator.
  • Experimental: MK-1084 + Cetuximab
    Participants will receive MK-1084 and cetuximab until discontinuation due to toxicity, AE or at the discretion of an investigator.

Primary Outcome Measure

Number of Participants Who Experience a Dose Limiting Toxicity (DLT) [ Time Frame: Up to 42 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Clermont Oncology Center ( Site 0041)ClermontFlorida34711
Study Coordinator
386-538-3169
University of Illinois Hospital & Health Sciences System ( Site 0044)ChicagoIllinois60612
Study Coordinator
312-996-9272

Find similar trials in Clermont, FL

By research site
Clermont Oncology Center· Clermont, FLUniversity of Illinois Hospital & Health Sciences System· Chicago, IL

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