A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Condition(s) studied
Investigational drug(s) / intervention(s)
Raludotatug Deruxtecan: IV Infusion
Ifinatamab Deruxtecan: IV Infusion
Docetetaxel: IV Infusion
5-hydroxytryptamine subtype 3 receptor antagonist: Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
Neurokinin-1 receptor antagonist: Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion
Corticosteroid: 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
Study 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
Primary outcome measure(s)
- Objective Response Rate (ORR) — Up to approximately 81 months
ORR is defined as the percentage of participants with Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. - Percentage of Participants with at Least One Adverse Event (AE) — Up to approximately 81 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who experience an AE will be reported. - Percentage of Participants Who Discontinued Medication Due to an AE — Up to approximately 24 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who discontinue study intervention due to an AE will be reported.
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Kentucky Chandler Medical Center ( Site 0019) | Lexington | Kentucky | |
| MedStar Franklin Square Medical Center ( Site 0033) | Baltimore | Maryland | |
| AHN Cancer Institute - Allegheny General ( Site 9501) | Pittsburgh | Pennsylvania | |
| Texas Oncology - DFW ( Site 8003) | Dallas | Texas | |
| Centro de Estudios Clínicos SAGA ( Site 0161) | Santiago | Region M. de Santiago | |
| Fundación Arturo López Pérez ( Site 0160) | Santiago | Region M. de Santiago | |
| Bradfordhill ( Site 0162) | Santiago | Region M. de Santiago | |
| Universitaetsklinik Tuebingen ( Site 0192) | Tübingen | Baden-Wurttemberg | |
| 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 | |
| European Interbalkan Medical Center ( Site 0205) | Thessaloniki | Greece | |
| Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063) | Kecskemét | Bács-Kiskun county | |
| Petz Aladar Egyetemi Oktato Korhaz ( Site 0062) | Győr | Győr-Moson-Sopron | |
| Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061) | Szolnok | Jász-Nagykun-Szolnok | |
| Református Pulmonológiai Centrum ( Site 0064) | Törökbálint | Pest County | |
| 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 | |
| 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 | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151) | Warsaw | Masovian Voivodeship | |
| Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150) | Gdansk | Pomeranian Voivodeship | |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152) | Koszalin | West Pomeranian Voivodeship | |
| Institut Català d'Oncologia - L'Hospitalet ( Site 0090) | L'Hospitalet de Llobregat | Barcelona | |
| 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) | |
| Ankara Bilkent Şehir Hastanesi. ( Site 0142) | Ankara | Turkey (Türkiye) | |
| I. U. Cerrahpasa Tip Fakultesi ( Site 0144) | Istanbul | Turkey (Türkiye) | |
| Ege Universitesi Hastanesi ( Site 0143) | Izmir | Turkey (Türkiye) |
More Merck Sharp & Dohme LLC trials in Turkey
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06780085 on ClinicalTrials.gov ↗ ← All trials in Turkey