Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06780098
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • R-DXD — BIOLOGICAL
    IV Infusion
  • I-DXD — BIOLOGICAL
    IV Infusion
  • Docetaxel — DRUG
    IV Infusion
  • Rescue Medications — DRUG
    Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines.
  • Rescue Medication — DRUG
    Participants are premedicated with corticosteroids per approved product label and following institutional standards or local guidelines.

Study Details

Researchers are looking for other ways to treat metastatic squamous non-small cell lung cancer (NSCLC). Squamous NSCLC is cancer that starts in squamous cells, which are flat cells that line the inside of the airways in the lungs. Metastatic means the cancer has spread to other parts of the body. Standard treatment (usual treatment) for metastatic squamous NSCLC is immunotherapy with or without chemotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. However, standard treatment may not work or may stop working to treat metastatic squamous NSCLC. Researchers want to learn if study treatments that are antibody drug conjugates (ADCs) can treat metastatic squamous NSCLC that did not respond (get smaller or go away) to standard treatment. An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The main goals of this study are to learn about: * The cancer response to the study treatments compared to chemotherapy * The safety of the study treatments and if people tolerate them This study is one of the substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

Key Dates

Start date
May 28, 2025
Status verified
May 2026
Primary completion
Mar 2, 2032
Completion
Mar 2, 2032

Study Design

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

Arms

  • Experimental: Arm 1: Raludotatug deruxtecan (R-DXD)
    Participants receive 5.6 mg/kg of R-DXD, every 3 weeks (Q3W) (Day 1 of every 21-day cycle) via intravenous (IV) infusion until progressive disease (PD) or discontinuation.
  • Experimental: Arm 2: Infinatamab deruxtecan (I-DXD) High Dose
    Participants receive 12 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.
  • Experimental: Arm 3: I-DXD Low Dose
    Participants receive 8 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.
  • Active Comparator: Arm 4: Docetaxel
    Participants receive 75 mg/m\^2 of Docetaxel, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.

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 condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Kentucky Chandler Medical Center· Lexington, KYMedStar Franklin Square Medical Center· Baltimore, MD

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