A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)

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

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-13

Study Completion Date

2032-03-12

Brief Summary

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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

Detailed Description

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

Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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Programmed Cell Death-1 (PD1, PD-1) Programmed Death-Ligand 1 (PDL1, PD-L1) Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Unblinded open-label

Study Groups

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Raludotatug Deruxtecan

Participants receive raludotatug deruxtecan (R-DXd) 5.6 mg/kg via intravenous (IV) Infusion every 3 weeks (q3w) until disease progression or discontinuation criterion is met.

Group Type EXPERIMENTAL

Raludotatug Deruxtecan

Intervention Type BIOLOGICAL

IV Infusion

Ifinatamab Deruxtecan

Participants receive ifinatamab deruxtecan (I-DXd) 12 mg/kg via IV infusion q3w until disease progression or discontinuation criterion is met.

Group Type EXPERIMENTAL

Ifinatamab Deruxtecan

Intervention Type BIOLOGICAL

IV Infusion

Docetetaxel

Participants receive docetaxel 75mg/m2 via IV infusion q3w until disease progression or discontinuation criterion is met.

Group Type ACTIVE_COMPARATOR

Docetetaxel

Intervention Type DRUG

IV Infusion

Interventions

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Raludotatug Deruxtecan

IV Infusion

Intervention Type BIOLOGICAL

Ifinatamab Deruxtecan

IV Infusion

Intervention Type BIOLOGICAL

Docetetaxel

IV Infusion

Intervention Type DRUG

Other Intervention Names

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R-DXd MK-5909 DS-6000a I-DXd MK-2400 DS-7300a

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of Stage IV nonsquamous non-small cell lung cancer (NSCLC)
* Documented disease progression per RECIST 1.1 after receiving an anti-programmed cell death 1 protein (PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy
* Confirmation per local test report that epidermal growth factor receptor negative (EGFR-), anaplastic lymphoma kinase negative (ALK-), or c ros oncogene 1 negative (ROS1-) directed therapy is not indicated as primary therapy
* Measurable disease per RECIST 1.1 as assessed by investigator and verified by BICR
* Life expectancy of at least 3 months
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
* Is an individual of any sex/gender who is at least 18 years of age at the time of providing the informed consent
* Has adequate organ function
* If capable of producing sperm refrains from donating sperm plus either abstains from penile-vaginal intercourse or uses a penile/external condom, with contraceptive use consistent with local regulations
* Participant/participants of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test; and is not breastfeeding and uses a highly effective contraceptive method
* Archival tumor tissue sample of a tumor lesion not previously irradiated has been provided
* Has provided tissue prior to treatment randomization from a newly obtained formalin-fixed sample from a new biopsy
* Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion Criteria

* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
* Received radiation therapy to the lung
* Has uncontrolled or significant cardiovascular disorder prior to randomization
* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
* Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
* Has known severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients
* Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection (including HIV infection)
* Has clinically significant corneal disease
* Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids
* Has inadequate washout period prior to randomization
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has 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
* Has evidence of any leptomeningeal disease
* Has history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and/or suspected ILD/pneumonitis
* Has active autoimmune disease that has required systemic treatment in the past 2 years
* Has active infection requiring systemic therapy
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
* Has known history of, or active, neurologic paraneoplastic syndrome
* Has history of allogeneic tissue/solid organ transplant
* Have not adequately recovered from major surgery or have ongoing surgical complications

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Identifier Type: -

Identifier Source: org_study_id

2024-518761-10-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-3475-01H

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1314-1785

Identifier Type: REGISTRY

Identifier Source: secondary_id

KEYMAKER-U01

Identifier Type: OTHER

Identifier Source: secondary_id

A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Raludotatug Deruxtecan

Raludotatug Deruxtecan

Ifinatamab Deruxtecan

Ifinatamab Deruxtecan

Docetetaxel

Docetetaxel

Interventions

Raludotatug Deruxtecan

Ifinatamab Deruxtecan

Docetetaxel

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Daiichi Sankyo

Merck Sharp & Dohme LLC

Responsible Party

Principal Investigators

Medical Director

Locations

University of Kentucky Chandler Medical Center ( Site 0019)

MedStar Franklin Square Medical Center ( Site 0033)

Centro de Estudios Clínicos SAGA ( Site 0161)

FALP ( Site 0160)

Bradfordhill ( Site 0162)

Universitaetsklinik Tuebingen ( Site 0192)

Charite-Universitaetsmedizin Berlin ( Site 0191)

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 0204)

European Interbalkan Medical Center ( Site 0205)

Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)

Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)

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

Rambam Health Care Campus ( Site 0076)

Shaare Zedek Medical Center ( Site 0075)

Meir Medical Center ( Site 0071)

Rabin Medical Center ( Site 0074)

Sheba Medical Center ( Site 0070)

Sourasky Medical Center ( Site 0077)

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

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

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)

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

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

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

Hospital Universitario Quiron Madrid ( Site 0091)

Countries

Central Contacts

Toll Free Number

Facility Contacts

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