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) (NCT06780098)
KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC)
🩺 Plain-English Summary (8th-Grade Level)
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).
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 (44 Sites)
Showing the first 25 of 44 sites.
- University of Kentucky Chandler Medical Center ( Site 0019) — Lexington, Kentucky
- MedStar Franklin Square Medical Center ( Site 0033) — Baltimore, Maryland
- Texas Oncology - DFW ( Site 8003) — Dallas, Texas
- 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
- Beijing Cancer Hospital ( Site 0301) — Beijing, Beijing Municipality
- Chongqing University Cancer Hospital ( Site 0304) — Chongqing, Chongqing Municipality
- Fujian Provincial Cancer Hospital ( Site 0310) — Fuzhou, Fujian
- Guangxi Medical University Cancer Hospital ( Site 0303) — Nanning, Guangxi
- Henan Cancer Hospital ( Site 0311) — Zhengzhou, Henan
- Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309) — Nanjing, Jiangsu
- Shanghai Chest Hospital ( Site 0308) — Shanghai, Shanghai Municipality
- Shanghai Pulmonary Hospital ( Site 0300) — Shanghai, Shanghai Municipality
- UniversitaetsklInikum Tuebingen ( Site 0192) — Tübingen, Baden-Wurttemberg
- Charite-Universitaetsmedizin Berlin ( Site 0191) — Berlin,
- EVANGELISMOS S.A ( Site 0206) — Athens, Attica
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204) — Athens, Attica
- European Interbalkan Medical Center-Oncology Department ( 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,
📞 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.