RecruitingPhase 2NCT06780085

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

KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC)


Sponsor

Merck Sharp & Dohme LLC

Enrollment

96 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a clinical trial testing new investigational drugs in combination with pembrolizumab (a well-known immunotherapy) in patients with advanced (Stage IV) non-squamous non-small cell lung cancer (NSCLC) — such as lung adenocarcinoma — that has progressed after standard treatments. The study aims to find new options for patients whose cancer has already been treated. **You may be eligible if...** - You have been diagnosed with Stage IV non-squamous NSCLC (such as adenocarcinoma) - Your cancer has progressed after receiving an immunotherapy checkpoint inhibitor (anti-PD-1/PD-L1) and platinum-based chemotherapy - Your cancer does not have EGFR, ALK, or ROS1 mutations that would direct you to targeted therapy - Your cancer is measurable on imaging - You are 18 years of age or older **You may NOT be eligible if...** - Your cancer has actionable genetic mutations (like EGFR or ALK) that have specific approved treatments - You have certain active autoimmune conditions, or other conditions that conflict with immunotherapy - You have uncontrolled HIV or active hepatitis B/C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRaludotatug Deruxtecan

IV Infusion

BIOLOGICALIfinatamab Deruxtecan

IV Infusion

DRUGDocetetaxel

IV Infusion

DRUG5-hydroxytryptamine subtype 3 receptor antagonist

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion

DRUGNeurokinin-1 receptor antagonist

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion

DRUGCorticosteroid

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration


Locations(32)

University of Kentucky Chandler Medical Center ( Site 0019)

Lexington, Kentucky, United States

MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, Maryland, United States

Texas Oncology - DFW ( Site 8003)

Dallas, Texas, United States

Centro de Estudios Clínicos SAGA ( Site 0161)

Santiago, Region M. de Santiago, Chile

FALP ( Site 0160)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0162)

Santiago, Region M. de Santiago, Chile

Universitaetsklinik Tuebingen ( Site 0192)

Tübingen, Baden-Wurttemberg, Germany

Charite-Universitaetsmedizin Berlin ( Site 0191)

Berlin, Germany

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

Athens, Attica, Greece

European Interbalkan Medical Center ( Site 0205)

Thessaloniki, Greece

Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)

Kecskemét, Bács-Kiskun county, Hungary

Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)

Győr, Győr-Moson-Sopron, Hungary

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

Szolnok, Jász-Nagykun-Szolnok, Hungary

Rambam Health Care Campus ( Site 0076)

Haifa, Israel

Shaare Zedek Medical Center ( Site 0075)

Jerusalem, Israel

Meir Medical Center ( Site 0071)

Kfar Saba, Israel

Rabin Medical Center ( Site 0074)

Petah Tikva, Israel

Sheba Medical Center ( Site 0070)

Ramat Gan, Israel

Sourasky Medical Center ( Site 0077)

Tel Aviv, Israel

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)

Milan, Lombardy, Italy

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

Florence, Italy

Ospedale San Raffaele. ( Site 0171)

Milan, Italy

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

Roma, Italy

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)

Poznan, Greater Poland Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

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

Koszalin, West Pomeranian Voivodeship, Poland

Institut Català d'Oncologia - L'Hospitalet ( Site 0090)

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Quiron Madrid ( Site 0091)

Madrid, Spain

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)

Adana, Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)

Ankara, Turkey (Türkiye)

I. U. Cerrahpasa Tip Fakultesi ( Site 0144)

Istanbul, Turkey (Türkiye)

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NCT06780085