A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06780085
Phase
PHASE2
Status
Recruiting
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Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Raludotatug Deruxtecan — BIOLOGICAL
    IV Infusion
  • Ifinatamab Deruxtecan — BIOLOGICAL
    IV Infusion
  • Docetetaxel — DRUG
    IV Infusion
  • 5-hydroxytryptamine subtype 3 receptor antagonist — DRUG
    Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
  • Neurokinin-1 receptor antagonist — DRUG
    Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
  • Corticosteroid — DRUG
    Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration

Study Details

Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs. Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing. However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells. Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn: * About the safety of the study treatments and if people tolerate them * How many people have the cancer respond to the study treatments

Key Dates

Start date
May 13, 2025
Status verified
May 2026
Primary completion
Mar 12, 2032
Completion
Mar 12, 2032

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Raludotatug Deruxtecan
    Participants receive raludotatug deruxtecan (R-DXd) 5.6 mg/kg via intravenous (IV) Infusion every 3 weeks (q3w) until disease progression or discontinuation criterion is met.
  • Experimental: Ifinatamab Deruxtecan
    Participants receive ifinatamab deruxtecan (I-DXd) 12 mg/kg via IV infusion q3w until disease progression or discontinuation criterion is met.
  • Active Comparator: Docetetaxel
    Participants receive docetaxel 75mg/m2 via IV infusion q3w until disease progression or discontinuation criterion is met.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 81 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kentucky Chandler Medical Center ( Site 0019)LexingtonKentucky40536-0293
Study Coordinator
859-257-1000
MedStar Franklin Square Medical Center ( Site 0033)BaltimoreMaryland21237
Study Coordinator
443-777-7147

Find similar trials in Lexington, KY

By research site
University of Kentucky Chandler Medical Center· Lexington, KYMedStar Franklin Square Medical Center· Baltimore, MD

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