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OncoMatch/Clinical Trials/NCT06780098

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)

Is NCT06780098 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for lung neoplasm.

Phase 2RecruitingMerck Sharp & Dohme LLCNCT06780098Data as of May 2026

Treatment: R-DXD · I-DXD · Docetaxel · Rescue Medications · Rescue MedicationResearchers 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).

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Disease stage

Required: Stage IV

Metastatic disease required

Prior therapy

Min 2 prior lines

Must have received: anti-PD-1 therapy — for Stage IV disease

disease progression...after receiving an anti-programmed cell death protein 1 (anti-PD-1)...treatment

Must have received: anti-PD-L1 therapy — for Stage IV disease

disease progression...after receiving...programmed cell death ligand 1 (PD-L1) treatment

Must have received: platinum-based chemotherapy — for Stage IV disease

disease progression...after receiving...platinum-based chemotherapy for Stage IV disease

Cannot have received: docetaxel (docetaxel)

Has previously received docetaxel as monotherapy or in combination with other therapies

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Kentucky Chandler Medical Center ( Site 0019) · Lexington, Kentucky
  • MedStar Franklin Square Medical Center ( Site 0033) · Baltimore, Maryland

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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