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A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
NCT06780085 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06780085
The ClinicalTrials.gov registry entry for NCT06780085 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 96 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 Carcinoma, Non-Small-Cell Lung appearing as the primary indexed condition, and to 5 interventions — of which Raludotatug Deruxtecan 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: NCT06780085 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Region M. de Santiago, Kentucky. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06780085?
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 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.
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