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Lung Neoplasm MalignantGeneticsCancerLungs and breathingDrugBiologicalPhase 1, Phase 2

What this study is

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

What's being tested

  • MK-1084

    Intervention · DRUG

    Oral administration

  • Patritumab deruxtecan

    Intervention · BIOLOGICAL

    IV infusion

  • Sacituzumab tirumotecan

    Intervention · BIOLOGICAL

  • Cetuximab

    Intervention · BIOLOGICAL

  • Rescue Medications

    Intervention · DRUG

    Participants receive rescue medication at the investigator's discretion for prevention of nausea and vomiting, per approved product label. Recommended rescue medications are histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent), 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist and corticosteroid.

Both Sacituzumab tirumotecan and Cetuximab

IV Infusion

Study details

Official title
KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
Sponsor
Merck Sharp & Dohme LLC
Conditions
Lung Neoplasm Malignant
Enrolling
140 people
Starts
2026-04-30
Est. completion
2032-04-13
Design
Open-label, randomized, sequential groups, Phase 1, Phase 2
Record
View on ClinicalTrials.gov ↗