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Lung NeoplasmCancerLungs and breathingBiologicalDrugPhase 2

What this study is

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).

What's being tested

  • R-DXD

    Intervention · BIOLOGICAL

  • I-DXD

    Intervention · BIOLOGICAL

  • Docetaxel

    Intervention · DRUG

  • Rescue Medications

    Intervention · 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

    Intervention · DRUG

    Participants are premedicated with corticosteroids per approved product label and following institutional standards or local guidelines.

All of R-DXD, I-DXD, Docetaxel

IV Infusion

Study details

Official title
KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC)
Sponsor
Merck Sharp & Dohme LLC
Conditions
Lung Neoplasm
Enrolling
144 people
Starts
2025-05-28
Est. completion
2032-03-02
Design
Single-blind, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗