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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)
NCT06780098 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Rescue Medication
- DRUG Rescue Medications
- BIOLOGICAL R-DXD
- BIOLOGICAL I-DXD
Study Locations (20)
Region M. de Santiago
- Centro de Estudios Clínicos SAGA ( Site 0161) — Santiago
- FALP ( Site 0160) — Santiago
- Bradfordhill ( Site 0162) — Santiago
Other
- Charite-Universitaetsmedizin Berlin ( Site 0191) — Berlin
- European Interbalkan Medical Center-Oncology Department ( Site 0205) — Thessaloniki
- Rambam Health Care Campus ( Site 0076) — Haifa
Shanghai Municipality
- Shanghai Chest Hospital ( Site 0308) — Shanghai
- Shanghai Pulmonary Hospital ( Site 0300) — Shanghai
Kentucky
- University of Kentucky Chandler Medical Center ( Site 0019) — Lexington
Maryland
- MedStar Franklin Square Medical Center ( Site 0033) — Baltimore
Chongqing Municipality
- Chongqing University Cancer Hospital ( Site 0304) — Chongqing
Fujian
- Fujian Provincial Cancer Hospital ( Site 0310) — Fuzhou
Guangxi
- Guangxi Medical University Cancer Hospital ( Site 0303) — Nanning
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2025-05-28 |
| Est. Completion | 2032-03-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06780098
The ClinicalTrials.gov registry entry for NCT06780098 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Lung Neoplasm appearing as the primary indexed condition, and to 5 interventions — of which Docetaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06780098 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Region M. de Santiago, Other, Shanghai Municipality. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06780098 about?
NCT06780098 is a clinical study titled "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)". 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. S...
What is the current status of trial NCT06780098?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 144 participants. The study started on 2025-05-28. Estimated completion is 2032-03-02.
What conditions does trial NCT06780098 study?
This clinical trial studies the following conditions: Lung Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06780098?
The interventions under investigation include: Docetaxel (DRUG), Rescue Medication (DRUG), Rescue Medications (DRUG), R-DXD (BIOLOGICAL), I-DXD (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06780098?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06780098 being conducted?
This trial has 20 study locations across Kentucky, Maryland, Region M. de Santiago, Chongqing Municipality, Fujian. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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