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NCT06780098 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Lung Neoplasm, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 144
- Enrollment target
- 20
- Study locations
NCT06780098 is a Phase 2 study of Lung Neoplasm that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 144 participants, below the 537-participant average among 8 other Lung Neoplasm trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT06780098, a Phase 2 study of Lung Neoplasm, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 144 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 537-participant average among 8 other Lung Neoplasm trials with a reported enrollment target (73% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT06780098 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Region M. de Santiago, Other, Shanghai Municipality.
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.
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).
Who is sponsoring clinical trial NCT06780098?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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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