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NCT06780085 · ClinicalTrials.gov registry record · Phase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
A Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 20
- Study locations
NCT06780085: Recruiting Phase 2 study of Carcinoma, Non-Small Cell Lung, sponsored by Merck Sharp & Dohme.
NCT06780085 is a Phase 2 study of Carcinoma, Non-Small Cell Lung that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 96 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06780085, a Phase 2 study of Carcinoma, Non-Small Cell Lung, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 20
- Study locations
Study Summary
Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs. Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing. However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells. Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn: * About the safety of the study treatments and if people tolerate them * How many people have the cancer respond to the study treatments
Primary Outcome
ORR is defined as the percentage of participants with Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Conditions Studied
Interventions
- BIOLOGICAL Raludotatug Deruxtecan
- BIOLOGICAL Ifinatamab Deruxtecan
- DRUG Docetetaxel
- DRUG 5-hydroxytryptamine subtype 3 receptor antagonist
- DRUG Neurokinin-1 receptor antagonist
Study Locations (20)
Other
- Charite-Universitaetsmedizin Berlin ( Site 0191) - Berlin
- European Interbalkan Medical Center ( Site 0205) - Thessaloniki
- Rambam Health Care Campus ( Site 0076) - Haifa
- Shaare Zedek Medical Center ( Site 0075) - Jerusalem
- Meir Medical Center ( Site 0071) - Kfar Saba
- Rabin Medical Center ( Site 0074) - Petah Tikva
- Sheba Medical Center ( Site 0070) - Ramat Gan
- Sourasky Medical Center ( Site 0077) - Tel Aviv
- Azienda Ospedaliera Universitaria Careggi ( Site 0173) - Florence
Region M. de Santiago
- Centro de Estudios Clínicos SAGA ( Site 0161) - Santiago
- FALP ( Site 0160) - Santiago
- Bradfordhill ( Site 0162) - Santiago
Kentucky
- University of Kentucky Chandler Medical Center ( Site 0019) - Lexington
Maryland
- MedStar Franklin Square Medical Center ( Site 0033) - Baltimore
Baden-Wurttemberg
- Universitaetsklinik Tuebingen ( Site 0192) - Tübingen
Attica
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 0204) - Athens
Bács-Kiskun county
- Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063) - Kecskemét
Győr-Moson-Sopron
- Petz Aladar Egyetemi Oktato Korhaz ( Site 0062) - Győr
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2025-05-13 |
| Est. Completion | 2032-03-12 |
| Phase | Phase 2 |
What NCT06780085 shows while recruiting
NCT06780085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 5 interventions - of which Raludotatug Deruxtecan is the first listed.
NCT06780085 names 20 study sites across 10 states, led by Other, Region M. de Santiago, Kentucky.
Frequently Asked Questions
What is clinical trial NCT06780085 about?
NCT06780085 is a clinical study titled "A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)". Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the in...
What is the current status of trial NCT06780085?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2025-05-13. Estimated completion is 2032-03-12.
What conditions does trial NCT06780085 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT06780085?
The interventions under investigation include: Raludotatug Deruxtecan (BIOLOGICAL), Ifinatamab Deruxtecan (BIOLOGICAL), Docetetaxel (DRUG), 5-hydroxytryptamine subtype 3 receptor antagonist (DRUG), Neurokinin-1 receptor antagonist (DRUG).
Who is sponsoring clinical trial NCT06780085?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06780085 being conducted?
This trial has 20 study locations across Kentucky, Maryland, Region M. de Santiago, Baden-Wurttemberg, Attica. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06780085's enrollment target sits among peer trials
96 75th of 130 higher than 56 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung 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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