NCT06780098RecruitingPhase 2
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)
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)
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 13 Jan 2025
- Start date
- 28 May 2025
- Primary completion date
- 2 Mar 2032
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Lung cancer
- NCT number
- NCT06780098
- EU CT number
- 2024-518839-11-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 144
- From 28 May 2025 to the primary completion date, 2 Mar 2032
- 48 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), or prior pneumonectomy
- Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
- Has previously received docetaxel as monotherapy or in combination with other therapies
- Active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Has not adequately recovered from major surgery or have ongoing surgical complications
Other illness
- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- Has uncontrolled or significant cardiovascular disorder
- Has clinically significant corneal disease
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Evidence of any leptomeningeal disease
- Has one or more of the following indicators of interstitial lung disease (ILD)/pneumonitis: any history of ILD/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), current diagnosis of ILD, clinical or radiographic suspicion of ILD
- Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- Active infection requiring systemic therapy
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Known history of, or active, neurologic paraneoplastic syndrome
- History of allogeneic tissue/solid organ transplant
Other
- The main exclusion criteria include but are not limited to the following:
- Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
Who the study is looking for
- The main inclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC)
- Has documented disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1), as assessed by investigator after receiving an anti-programmed cell death protein 1 (anti-PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy for Stage IV disease
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Estudios Clínicos SAGA ( Site 0161) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Fundación Arturo López Pérez ( Site 0160) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Bradfordhill ( Site 0162) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Beijing Cancer Hospital ( Site 0301) Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Chongqing University Cancer Hospital ( Site 0304) Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Fujian Provincial Cancer Hospital ( Site 0310) Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309) Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Guangxi Medical University Cancer Hospital ( Site 0303) Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Shanghai Chest Hospital ( Site 0308) Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Pulmonary Hospital ( Site 0300) Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Henan Cancer Hospital ( Site 0311) Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| F. Therapis General Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Orszagos Koranyi Pulmonologiai Intezet Coordinator of this site? Confirm its status | Budapest XII | Hungary | Recruiting |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Recruiting |
| Bacs-Kiskun Varmegyei Oktatokorhaz Coordinator of this site? Confirm its status | Kecskemét | Hungary | Recruiting |
| Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet Coordinator of this site? Confirm its status | Szolnok | Hungary | Recruiting |
| Református Pulmonológiai Centrum Coordinator of this site? Confirm its status | Törökbálint | Hungary | Recruiting |
| Rambam Health Care Campus ( Site 0076) Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center ( Site 0075) Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Meir Medical Center ( Site 0071) Coordinator of this site? Confirm its status | Kfar Saba | Israel | Recruiting |
| Rabin Medical Center ( Site 0074) Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Sheba Medical Center ( Site 0070) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Sourasky Medical Center ( Site 0077) Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie Coordinator of this site? Confirm its status | Koszalin | Poland | Recruiting |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| MedStar Franklin Square Medical Center ( Site 0033) Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Texas Oncology - DFW ( Site 8003) Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Virginia Cancer Specialists (VCS) ( Site 0408) Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| University of Kentucky Chandler Medical Center ( Site 0019) Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141) Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Recruiting |
| Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Ankara Bilkent Şehir Hastanesi. ( Site 0142) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0144) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Ege Universitesi Hastanesi ( Site 0143) Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.