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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)

NCT ID: NCT06780098

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-28

Study Completion Date

2032-03-02

Brief Summary

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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).

Detailed Description

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The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798

Conditions

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Lung Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm 1: Raludotatug deruxtecan (R-DXD)

Participants receive 5.6 mg/kg of R-DXD, every 3 weeks (Q3W) (Day 1 of every 21-day cycle) via intravenous (IV) infusion until progressive disease (PD) or discontinuation.

Group Type EXPERIMENTAL

R-DXD

Intervention Type BIOLOGICAL

IV Infusion

Arm 2: Infinatamab deruxtecan (I-DXD) High Dose

Participants receive 12 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.

Group Type EXPERIMENTAL

I-DXD

Intervention Type BIOLOGICAL

IV Infusion

Arm 3: I-DXD Low Dose

Participants receive 8 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.

Group Type EXPERIMENTAL

I-DXD

Intervention Type BIOLOGICAL

IV Infusion

Arm 4: Docetaxel

Participants receive 75 mg/m\^2 of Docetaxel, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

IV Infusion

Interventions

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R-DXD

IV Infusion

Intervention Type BIOLOGICAL

I-DXD

IV Infusion

Intervention Type BIOLOGICAL

Docetaxel

IV Infusion

Intervention Type DRUG

Other Intervention Names

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Raludotatug deruxtecan MK-5909 DS-6000a Ifinatamab deruxtecan MK-2400 DS-7300a Taxotere®

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection (including HIV infection)
* Has clinically significant corneal disease
* 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
* History of (noninfectious) pneumonitis/Interstitial Lung Disease (ILD) that required steroids or has current pneumonitis/ILD, and/or suspected ILD/pneumonitis
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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University of Kentucky Chandler Medical Center ( Site 0019)

Lexington, Kentucky, United States

Site Status RECRUITING

MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, Maryland, United States

Site Status RECRUITING

Centro de Estudios Clínicos SAGA ( Site 0161)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

FALP ( Site 0160)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Bradfordhill ( Site 0162)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Fujian Provincial Cancer Hospital ( Site 0310)

Fuzhou, Fujian, China

Site Status RECRUITING

Guangxi Medical University Cancer Hospital ( Site 0303)

Nanning, Guangxi, China

Site Status RECRUITING

Henan Cancer Hospital ( Site 0311)

Zhengzhou, Henan, China

Site Status RECRUITING

Shanghai Pulmonary Hospital ( Site 0300)

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

UniversitaetsklInikum Tuebingen ( Site 0192)

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Charite-Universitaetsmedizin Berlin ( Site 0191)

Berlin, , Germany

Site Status RECRUITING

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204)

Athens, Attica, Greece

Site Status RECRUITING

European Interbalkan Medical Center-Oncology Department ( Site 0205)

Thessaloniki, , Greece

Site Status RECRUITING

Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)

Kecskemét, Bács-Kiskun county, Hungary

Site Status RECRUITING

Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)

Győr, Győr-Moson-Sopron, Hungary

Site Status RECRUITING

Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 0061)

Szolnok, Jász-Nagykun-Szolnok, Hungary

Site Status RECRUITING

Rambam Health Care Campus ( Site 0076)

Haifa, , Israel

Site Status RECRUITING

Shaare Zedek Medical Center ( Site 0075)

Jerusalem, , Israel

Site Status RECRUITING

Meir Medical Center ( Site 0071)

Kfar Saba, , Israel

Site Status RECRUITING

Rabin Medical Center ( Site 0074)

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center ( Site 0070)

Ramat Gan, , Israel

Site Status RECRUITING

Sourasky Medical Center ( Site 0077)

Tel Aviv, , Israel

Site Status RECRUITING

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

Florence, , Italy

Site Status RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)

Milan, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)

Roma, , Italy

Site Status RECRUITING

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)

Poznan, Greater Poland Voivodeship, Poland

Site Status RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)

Koszalin, West Pomeranian Voivodeship, Poland

Site Status RECRUITING

Hospital Clinic de Barcelona ( Site 0092)

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Quiron Madrid ( Site 0091)

Madrid, , Spain

Site Status RECRUITING

Countries

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United States Chile China Germany Greece Hungary Israel Italy Poland Spain

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Study Coordinator

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Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-3475-01I

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1314-2392

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024-518839-11-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

KEYMAKER-01I

Identifier Type: OTHER

Identifier Source: secondary_id

3475-01I

Identifier Type: -

Identifier Source: org_study_id