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

NCT ID: NCT05882734

Condition: Non-Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cemiplimab

Conditions: Keywords:
Ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor
Tuvusertib (M1774)
Non squamous Non small cell lung cancer
Cemiplimab

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: M1774
Description: 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.
Arm group label: Dosing Regimen 1 (Phase 1b): M1774 + Cemiplimab
Arm group label: Dosing Regimen 2 (Phase 1b): M1774 + Cemiplimab
Arm group label: Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
Arm group label: Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
Arm group label: Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b

Other name: Tuvusertib

Intervention type: Drug
Intervention name: Cemiplimab
Description: 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.
Arm group label: Dosing Regimen 1 (Phase 1b): M1774 + Cemiplimab
Arm group label: Dosing Regimen 2 (Phase 1b): M1774 + Cemiplimab
Arm group label: Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
Arm group label: Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
Arm group label: Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b

Summary: This is an Open-label, multicenter clinical study conducted in two Phases to establish the efficacy, safety, tolerability, and pharmacokinetics of the ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor Tuvusertib in Combination with Cemiplimab in Participants with Non-Squamous Non-Small Cell Lung Cancer (nsqNSCLC) that has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies..

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Participants who are diagnosed with nsqNSCLC histologically or cytologically confirmed - 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 - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Participants with tumors harboring actionable epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic aberrations. Participants with tumors with other actionable aberrations are eligible and allowed to have received up to 1 line of available targeted therapy - 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 - Other protocol defined exclusion criteria could apply

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UCLA Hematology and Oncology - Santa Monica

Address:
City: Santa Monica
Zip: 90404
Country: United States

Facility:
Name: UPMC Cancer Center

Address:
City: Pittsburgh
Zip: 15232
Country: United States

Facility:
Name: Tennessee Cancer Specialists - Biomedical Research

Address:
City: Knoxville
Zip: 37909
Country: United States

Facility:
Name: The University of Texas MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: Millennium Research & Clinical Development

Address:
City: Houston
Zip: 77090
Country: United States

Facility:
Name: Virginia Cancer Specialists, PC

Address:
City: Fairfax
Zip: 22031
Country: United States

Facility:
Name: Institut Jules Bordet - Department of Institut Jules Bordet'

Address:
City: Anderlecht
Country: Belgium

Facility:
Name: UZA - Oncology

Address:
City: Edegem
Country: Belgium

Facility:
Name: Jessa Ziekenhuis Hospital

Address:
City: Hasselt
Country: Belgium

Facility:
Name: Universitair Ziekenhuis Brussel - UZB

Address:
City: Jette
Country: Belgium

Facility:
Name: UZ Leuven

Address:
City: Leuven
Country: Belgium

Facility:
Name: CHU de Liège - PARENT

Address:
City: Liege
Country: Belgium

Facility:
Name: CHU Angers - Hôpital Larrey - Service de Pneumologie

Address:
City: Angers Cedex 9
Country: France

Facility:
Name: Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie

Address:
City: Creteil Cedex
Country: France

Facility:
Name: CHU Limoges - Hôpital Dupuytren - Unite d'Oncologie Thoracique et Cutanée

Address:
City: Limoges
Country: France

Facility:
Name: Hôpital de la Timone - CPCEM CIC - Bat F 1er étage

Address:
City: Marseille cedex 5
Country: France

Facility:
Name: Hopital Arnaud de Villeneuve - Service de Pneumologie-Addictologie

Address:
City: Montpellier cedex 05
Country: France

Facility:
Name: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires

Address:
City: Pessac
Country: France

Facility:
Name: ICO - Site René Gauducheau - Service d'Oncologie medicale

Address:
City: Saint Herblain Cedex
Country: France

Facility:
Name: Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik und Poliklinik III

Address:
City: Giessen
Country: Germany

Facility:
Name: Universitaetsklinikum Leipzig AoeR - Med. Klinik u. Poliklinik I - Abt. Pneumologie

Address:
City: Leipzig
Country: Germany

Facility:
Name: Sana Klinikum Offenbach GmbH - Medizinische Klinik IV

Address:
City: Offenbach
Country: Germany

Facility:
Name: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - U.O. Oncologia Medica

Address:
City: Bologna
Country: Italy

Facility:
Name: IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica

Address:
City: Milano
Country: Italy

Facility:
Name: Ospedale San Raffaele - U.O. di Oncologia Medica

Address:
City: Milano
Country: Italy

Facility:
Name: Istituto Nazionale Tumori Fondazione G. Pascale - Medical Oncology Thoraco-Pulmonary Department

Address:
City: Napoli
Country: Italy

Facility:
Name: Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B

Address:
City: Roma
Country: Italy

Facility:
Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

Address:
City: Rome
Country: Italy

Facility:
Name: Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia

Address:
City: Rozzano
Country: Italy

Facility:
Name: National Cancer Center Hospital

Address:
City: Chuo-ku
Country: Japan

Facility:
Name: Kansai Medical University Hospital

Address:
City: Hirakata-shi
Country: Japan

Facility:
Name: National Cancer Center Hospital East

Address:
City: Kashiwa-shi
Country: Japan

Facility:
Name: Cancer Institute Hospital of JFCR

Address:
City: Koto-ku
Country: Japan

Facility:
Name: Kurume University Hospital

Address:
City: Kurume-shi
Country: Japan

Facility:
Name: Aichi Cancer Center Hospital

Address:
City: Nagoya-shi
Country: Japan

Facility:
Name: Kindai University Hospital

Address:
City: Osakasayama-shi
Country: Japan

Facility:
Name: Kanagawa Cancer Center

Address:
City: Yokohama-shi
Country: Japan

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Severance Hospital, Yonsei University Health System - Division of Infectious Diseases

Address:
City: Seoul
Country: Korea, Republic of

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

Address:
City: Seoul
Country: Korea, Republic of

Facility:
Name: Hospital Clinic de Barcelona - Servicio de Oncologia

Address:
City: Barcelona
Country: Spain

Facility:
Name: Hospital Universitari Vall d'Hebron - Oncology Dept.

Address:
City: Barcelona
Country: Spain

Facility:
Name: Hospital Universitario Reina Sofia - Dept of Oncology

Address:
City: Córdoba
Country: Spain

Facility:
Name: Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica