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)
KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC)
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: University of Kentucky Chandler Medical Center ( Site 0019) — Lexington, Kentucky
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (34 Sites)
Showing the first 25 of 34 sites.
- University of Kentucky Chandler Medical Center ( Site 0019) — Lexington, Kentucky
- MedStar Franklin Square Medical Center ( Site 0033) — Baltimore, Maryland
- AHN Cancer Institute - Allegheny General ( Site 9501) — Pittsburgh, Pennsylvania
- Centro de Estudios Clínicos SAGA ( Site 0161) — Santiago, Region M. de Santiago
- FALP ( Site 0160) — Santiago, Region M. de Santiago
- Bradfordhill ( Site 0162) — Santiago, Region M. de Santiago
- Universitaetsklinik Tuebingen ( Site 0192) — Tübingen, Baden-Wurttemberg
- Charite-Universitaetsmedizin Berlin ( Site 0191) — Berlin,
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 0204) — Athens, Attica
- European Interbalkan Medical Center ( Site 0205) — Thessaloniki,
- Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063) — Kecskemét, Bács-Kiskun county
- Petz Aladar Egyetemi Oktato Korhaz ( Site 0062) — Győr, Győr-Moson-Sopron
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061) — Szolnok, Jász-Nagykun-Szolnok
- 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,
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175) — Milan, Lombardy
- Azienda Ospedaliera Universitaria Careggi ( Site 0173) — Florence,
- Ospedale San Raffaele. ( Site 0171) — Milan,
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174) — Roma,
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153) — Poznan, Greater Poland Voivodeship
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151) — Warsaw, Masovian Voivodeship
📞 Contact the Study Coordinator
Phone: (888) 577-8839
Email: Trialsites@msd.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.