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)

Recruiting now · Phase 2

Conditions studied: Lung Neoplasm

In brief

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).

Key facts

Study ID: NCT06780098
Run by: Merck Sharp & Dohme LLC
People needed: 144
Starts: 2025-05-28
Expected to finish: 2032-03-02
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

The main exclusion criteria include but are not limited to the following:
Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
Has uncontrolled or significant cardiovascular disorder
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 clinically significant corneal disease
Has previously received docetaxel as monotherapy or in combination with other therapies
Known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
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
Active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
Known history of, or active, neurologic paraneoplastic syndrome
History of allogeneic tissue/solid organ transplant
Has not adequately recovered from major surgery or have ongoing surgical complications

Where it is running

University of Kentucky Chandler Medical Center ( Site 0019) — Lexington, Kentucky, United States (enrolling)
MedStar Franklin Square Medical Center ( Site 0033) — Baltimore, Maryland, United States (enrolling)
Texas Oncology - DFW ( Site 8003) — Dallas, Texas, United States (enrolling)
Centro de Estudios Clínicos SAGA ( Site 0161) — Santiago, Region M. de Santiago, Chile (enrolling)
FALP ( Site 0160) — Santiago, Region M. de Santiago, Chile (enrolling)
Bradfordhill ( Site 0162) — Santiago, Region M. de Santiago, Chile (enrolling)
Beijing Cancer Hospital ( Site 0301) — Beijing, Beijing Municipality, China (enrolling)
Hospital Universitario Quiron Madrid ( Site 0091) — Madrid, Spain (enrolling)
Ege Universitesi Hastanesi ( Site 0143) — Izmir, İzmir, Turkey (Türkiye) (enrolling)
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141) — Adana, Turkey (Türkiye) (enrolling)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140) — Ankara, Turkey (Türkiye) (enrolling)
Ankara Bilkent Şehir Hastanesi. ( Site 0142) — Ankara, Turkey (Türkiye) (enrolling)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0144) — Istanbul, Turkey (Türkiye) (enrolling)
Chongqing University Cancer Hospital ( Site 0304) — Chongqing, Chongqing Municipality, China (enrolling)
Fujian Provincial Cancer Hospital ( Site 0310) — Fuzhou, Fujian, China (enrolling)
Guangxi Medical University Cancer Hospital ( Site 0303) — Nanning, Guangxi, China (enrolling)
Henan Cancer Hospital ( Site 0311) — Zhengzhou, Henan, China (enrolling)
Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309) — Nanjing, Jiangsu, China (enrolling)
Shanghai Chest Hospital ( Site 0308) — Shanghai, Shanghai Municipality, China (enrolling)
Shanghai Pulmonary Hospital ( Site 0300) — Shanghai, Shanghai Municipality, China (enrolling)
UniversitaetsklInikum Tuebingen ( Site 0192) — Tübingen, Baden-Wurttemberg, Germany (enrolling)
Charite-Universitaetsmedizin Berlin ( Site 0191) — Berlin, Germany (enrolling)
EVANGELISMOS S.A ( Site 0206) — Athens, Attica, Greece (enrolling)
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204) — Athens, Attica, Greece (enrolling)
European Interbalkan Medical Center-Oncology Department ( Site 0205) — Thessaloniki, Greece (enrolling)

Full record on ClinicalTrials.gov

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