Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)
NCT ID: NCT05882734
Last Updated: 2025-10-14
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
61 participants
INTERVENTIONAL
2023-09-13
2026-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dosing Regimen 1 (Phase 1b): M1774 + Cemiplimab
M1774
In Phase 1b, M1774 will be administered as dosing regimen 1 or dosing regimen 2 until disease progression, death discontinuation criteria or any other reason. The selected dosing regimen of M1774 will be administered in all arms of Phase 2a.
Cemiplimab
Cemiplimab will be administered as an intravenous infusion every 3 weeks in all arms of Phase 1b and Phase 2a until disease progression, death discontinuation criteria or any other reason.
Dosing Regimen 2 (Phase 1b): M1774 + Cemiplimab
M1774
In Phase 1b, M1774 will be administered as dosing regimen 1 or dosing regimen 2 until disease progression, death discontinuation criteria or any other reason. The selected dosing regimen of M1774 will be administered in all arms of Phase 2a.
Cemiplimab
Cemiplimab will be administered as an intravenous infusion every 3 weeks in all arms of Phase 1b and Phase 2a until disease progression, death discontinuation criteria or any other reason.
Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
M1774
In Phase 1b, M1774 will be administered as dosing regimen 1 or dosing regimen 2 until disease progression, death discontinuation criteria or any other reason. The selected dosing regimen of M1774 will be administered in all arms of Phase 2a.
Cemiplimab
Cemiplimab will be administered as an intravenous infusion every 3 weeks in all arms of Phase 1b and Phase 2a until disease progression, death discontinuation criteria or any other reason.
Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
M1774
In Phase 1b, M1774 will be administered as dosing regimen 1 or dosing regimen 2 until disease progression, death discontinuation criteria or any other reason. The selected dosing regimen of M1774 will be administered in all arms of Phase 2a.
Cemiplimab
Cemiplimab will be administered as an intravenous infusion every 3 weeks in all arms of Phase 1b and Phase 2a until disease progression, death discontinuation criteria or any other reason.
Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
M1774
In Phase 1b, M1774 will be administered as dosing regimen 1 or dosing regimen 2 until disease progression, death discontinuation criteria or any other reason. The selected dosing regimen of M1774 will be administered in all arms of Phase 2a.
Cemiplimab
Cemiplimab will be administered as an intravenous infusion every 3 weeks in all arms of Phase 1b and Phase 2a until disease progression, death discontinuation criteria or any other reason.
Interventions
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M1774
In Phase 1b, M1774 will be administered as dosing regimen 1 or dosing regimen 2 until disease progression, death discontinuation criteria or any other reason. The selected dosing regimen of M1774 will be administered in all arms of Phase 2a.
Cemiplimab
Cemiplimab will be administered as an intravenous infusion every 3 weeks in all arms of Phase 1b and Phase 2a until disease progression, death discontinuation criteria or any other reason.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with Radiologically confirmed/documented disease progression during or after the following systemic therapies (all required):
* At most, 1 line of anti-PD-(L)1 therapy for locally advanced or metastatic disease. Rechallenge with the same anti-PD-(L)1 for disease considered sensitive to anti-PD-(L)1 therapy (e.g. after a treatment break) is considered 1 line
* Platinum-based therapy for locally advanced or metastatic disease, given in combination or sequentially with anti-PD-(L)1 therapy. Participants who received adjuvant platinum-based therapy meet this criterion if disease progression occurred within 6 months from the last dose that the participant received that therapy. No additional cytotoxic therapies after progression on platinum-based therapy are allowed
* Prior best overall response of stable disease or better with anti-PD-(L)1 therapy
* Disease progression must have occurred while the participant has been receiving anti-PD-(L)1 therapy or within 16 weeks of the last dose of anti-PD-(L)1 therapy
* Participants with Measurable disease per RECIST v1.1
* Participants with Eastern Cooperative Oncology Group (ECOG) PS 0 or 1
* Adequate hematological, hepatic, and renal function as defined in the protocol.
* Phase 2a part only: central liquid biopsy analysis of tumor molecular alterations with an assay with appropriate regulatory status
Exclusion Criteria
* Participants with history of additional malignancy within 3 years before the date of enrollment. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years
* Participants with known brain metastases, unless clinically stable
* Participant with history of (noninfectious) pneumonitis that required systemic corticosteroids or current pneumonitis/interstitial lung disease
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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UCLA Hematology and Oncology - Santa Monica
Santa Monica, California, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
Tennessee Cancer Specialists - Biomedical Research
Knoxville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Millennium Research & Clinical Development
Houston, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Institut Jules Bordet - Department of Institut Jules Bordet'
Anderlecht, , Belgium
UZA - Oncology
Edegem, , Belgium
Jessa Ziekenhuis Hospital
Hasselt, , Belgium
Universitair Ziekenhuis Brussel - UZB
Jette, , Belgium
UZ Leuven
Leuven, , Belgium
CHU de Liège - PARENT
Liège, , Belgium
CHU Angers - Hôpital Larrey - Service de Pneumologie
Angers, , France
Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie
Créteil, , France
CHU Limoges - Hôpital Dupuytren - Unite d'Oncologie Thoracique et Cutanée
Limoges, , France
Hôpital de la Timone - CPCEM CIC - Bat F 1er étage
Marseille, , France
Hopital Arnaud de Villeneuve - Service de Pneumologie-Addictologie
Montpellier, , France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires
Pessac, , France
ICO - Site René Gauducheau - Service d'Oncologie medicale
Saint-Herblain, , France
Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik und Poliklinik III
Giessen, , Germany
Universitaetsklinikum Leipzig AoeR - Med. Klinik u. Poliklinik I - Abt. Pneumologie
Leipzig, , Germany
Sana Klinikum Offenbach GmbH - Medizinische Klinik IV
Offenbach, , Germany
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - U.O. Oncologia Medica
Bologna, , Italy
IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica
Milan, , Italy
Ospedale San Raffaele - U.O. di Oncologia Medica
Milan, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale - Medical Oncology Thoraco-Pulmonary Department
Napoli, , Italy
Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Rome, , Italy
Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia
Rozzano, , Italy
National Cancer Center Hospital
Chūōku, , Japan
Kansai Medical University Hospital
Hirakata-shi, , Japan
National Cancer Center Hospital East
Kashiwa-shi, , Japan
Cancer Institute Hospital of JFCR
Kōtoku, , Japan
Kurume University Hospital
Kurume-shi, , Japan
Aichi Cancer Center Hospital
Nagoya, , Japan
Kindai University Hospital
Osakasayama-shi, , Japan
Kanagawa Cancer Center
Yokohama, , Japan
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona, , Spain
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona, , Spain
Hospital Universitario Reina Sofia - Dept of Oncology
Córdoba, , Spain
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid, , Spain
Hospital Universitario 12 de Octubre - Servicio de Oncologia
Madrid, , Spain
Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia
Madrid, , Spain
Hospital Universitario La Paz - Oncology Department
Madrid, , Spain
Hospital Universitario Ramon y Cajal - Servicio de Oncologia
Madrid, , Spain
Hospital Regional Universitario de Malaga - Oncology Dept
Málaga, , Spain
Hospital Universitario Nuestra Señora de Valme - Servicio de Oncologia
Seville, , Spain
Hospital Universitario Virgen del Rocio - Oncology Service
Seville, , Spain
Hospital Universitario Virgen Macarena - Oncology Service
Seville, , Spain
Hospital Universitari i Politecnic La Fe - Oncology Department
Valencia, , Spain
Countries
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Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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2022-502010-85-00
Identifier Type: OTHER
Identifier Source: secondary_id
MS201924_0022
Identifier Type: -
Identifier Source: org_study_id
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