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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 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.

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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

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

FieldValue
Enrollment Target 96 participants
Start Date 2025-05-13
Est. Completion 2032-03-12
Phase Phase 2

Sponsor

Merck Sharp & Dohme

558 total trials

What the Registry Record Tells You About NCT06780085

The ClinicalTrials.gov registry entry for NCT06780085 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (70% 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 Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 5 interventions - of which Raludotatug Deruxtecan is the first listed.

NCT06780085 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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