Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

September 13, 2023

Primary Completion Date

March 30, 2026

Study Completion Date

March 30, 2026

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

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.

DRUG

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.

Trial Locations (54)

15232

UPMC Cancer Center, Pittsburgh

22031

Virginia Cancer Specialists, PC, Fairfax

37909

Tennessee Cancer Specialists - Biomedical Research, Knoxville

77030

The University of Texas MD Anderson Cancer Center, Houston

77090

Millennium Research & Clinical Development, Houston

90404

UCLA Hematology and Oncology - Santa Monica, Santa Monica

Unknown

Institut Jules Bordet - Department of Institut Jules Bordet', Anderlecht

UZA - Oncology, Edegem

Jessa Ziekenhuis Hospital, Hasselt

Universitair Ziekenhuis Brussel - UZB, Jette

UZ Leuven, Leuven

CHU de Liège - PARENT, Liège

CHU Angers - Hôpital Larrey - Service de Pneumologie, Angers

Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie, Créteil

CHU Limoges - Hôpital Dupuytren - Unite d'Oncologie Thoracique et Cutanée, Limoges

Hôpital de la Timone - CPCEM CIC - Bat F 1er étage, Marseille

Hopital Arnaud de Villeneuve - Service de Pneumologie-Addictologie, Montpellier

Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires, Pessac

ICO - Site René Gauducheau - Service d'Oncologie medicale, Saint-Herblain

Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik und Poliklinik III, Giessen

Universitaetsklinikum Leipzig AoeR - Med. Klinik u. Poliklinik I - Abt. Pneumologie, Leipzig

Sana Klinikum Offenbach GmbH - Medizinische Klinik IV, Offenbach

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - U.O. Oncologia Medica, Bologna

IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica, Milan

Ospedale San Raffaele - U.O. di Oncologia Medica, Milan

Istituto Nazionale Tumori Fondazione G. Pascale - Medical Oncology Thoraco-Pulmonary Department, Napoli

Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B, Roma

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica, Rome

Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia, Rozzano

National Cancer Center Hospital, Chūōku

Kansai Medical University Hospital, Hirakata-shi

National Cancer Center Hospital East, Kashiwa-shi

Cancer Institute Hospital of JFCR, Kōtoku

Kurume University Hospital, Kurume-shi

Aichi Cancer Center Hospital, Nagoya

Kindai University Hospital, Osakasayama-shi

Kanagawa Cancer Center, Yokohama

Asan Medical Center, Seoul

Samsung Medical Center, Seoul

Severance Hospital, Yonsei University Health System - Division of Infectious Diseases, Seoul

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

Hospital Clinic de Barcelona - Servicio de Oncologia, Barcelona

Hospital Universitari Vall d'Hebron - Oncology Dept., Barcelona

Hospital Universitario Reina Sofia - Dept of Oncology, Córdoba

Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica, Madrid

Hospital Universitario 12 de Octubre - Servicio de Oncologia, Madrid

Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia, Madrid

Hospital Universitario La Paz - Oncology Department, Madrid

Hospital Universitario Ramon y Cajal - Servicio de Oncologia, Madrid

Hospital Regional Universitario de Malaga - Oncology Dept, Málaga

Hospital Universitario Nuestra Señora de Valme - Servicio de Oncologia, Seville

Hospital Universitario Virgen del Rocio - Oncology Service, Seville

Hospital Universitario Virgen Macarena - Oncology Service, Seville

Hospital Universitari i Politecnic La Fe - Oncology Department, Valencia

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY