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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: Recruiting Phase 2 study of Lung Neoplasm, sponsored by Merck Sharp & Dohme.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) as assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR will be assessed by Blinded Independent Central Review (BICR). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
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 |
What NCT06780098 shows while recruiting
NCT06780098 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 537-participant average among 8 other Lung Neoplasm trials with a reported enrollment target (73% lower).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
Similar trials for Lung Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06780098's enrollment target sits among peer trials
144 7th of 8 higher than 2 of 8 other Lung Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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