Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT05882734
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2023-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)
Sponsor:
Organization:
Raw JSON
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'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627974', 'term': 'cemiplimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-13', 'studyFirstSubmitDate': '2023-05-22', 'studyFirstSubmitQcDate': '2023-05-22', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1b/Phase 2a: Confirmed Overall response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 As assessed by Investigator', 'timeFrame': 'Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months'}, {'measure': 'Phase 1b: Number of Participants With Adverse Events (AEs) and Treatment-related AEs', 'timeFrame': 'Time from randomization to final assessment at end of safety follow-up visit approximately up to 3 years and 2 months'}], 'secondaryOutcomes': [{'measure': 'Phase 1b/Phase 2a: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator', 'timeFrame': 'Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months'}, {'measure': 'Phase 1b/Phase 2a: Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator', 'timeFrame': 'Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months'}, {'measure': 'Phase 1b/Phase 2a: Overall survival (OS)', 'timeFrame': 'Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months'}, {'measure': 'Phase 2a: Number of Participants With AEs and Treatment-related AEs', 'timeFrame': 'Time from randomization to final assessment at end of safety follow-up visit (approximately up to 3 years and 2 months)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor', 'Tuvusertib (M1774)', 'Non squamous Non small cell lung cancer', 'Cemiplimab'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS201924_0022', 'label': 'Trial Awareness and Transparency website'}, {'url': 'https://medical.emdserono.com/en_US/home.html', 'label': 'US Medical Information website, Medical Resources'}]}, 'descriptionModule': {'briefSummary': '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..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants who are diagnosed with nsqNSCLC histologically or cytologically confirmed\n* Participants with Radiologically confirmed/documented disease progression during or after the following systemic therapies (all required):\n\n * 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\n * 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\n * Prior best overall response of stable disease or better with anti-PD-(L)1 therapy\n * 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\n* Participants with Measurable disease per RECIST v1.1\n* Participants with Eastern Cooperative Oncology Group (ECOG) PS 0 or 1\n* Adequate hematological, hepatic, and renal function as defined in the protocol.\n* Phase 2a part only: central liquid biopsy analysis of tumor molecular alterations with an assay with appropriate regulatory status\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* 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\n* 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\n* Participants with known brain metastases, unless clinically stable\n* Participant with history of (noninfectious) pneumonitis that required systemic corticosteroids or current pneumonitis/interstitial lung disease\n* Other protocol defined exclusion criteria could apply"}, 'identificationModule': {'nctId': 'NCT05882734', 'briefTitle': 'Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (DDRiver NSCLC 322)', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMD Serono'}, 'officialTitle': 'An Open Label, Multicenter, Phase 1b/2a Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of the ATR Inhibitor M1774 in Combination With Cemiplimab in Participants With Non-Squamous Non-Small Cell Lung Cancer That Has Progressed on Prior Anti-PD-(L)1 and Platinum-based Therapies (DDRiver NSCLC 322)', 'orgStudyIdInfo': {'id': 'MS201924_0022'}, 'secondaryIdInfos': [{'id': '2022-502010-85-00', 'type': 'OTHER', 'domain': 'EU Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dosing Regimen 1 (Phase 1b): M1774 + Cemiplimab', 'interventionNames': ['Drug: M1774', 'Drug: Cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'Dosing Regimen 2 (Phase 1b): M1774 + Cemiplimab', 'interventionNames': ['Drug: M1774', 'Drug: Cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b', 'interventionNames': ['Drug: M1774', 'Drug: Cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b', 'interventionNames': ['Drug: M1774', 'Drug: Cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b', 'interventionNames': ['Drug: M1774', 'Drug: Cemiplimab']}], 'interventions': [{'name': 'M1774', 'type': 'DRUG', 'otherNames': ['Tuvusertib'], '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.', 'armGroupLabels': ['Dosing Regimen 1 (Phase 1b): M1774 + Cemiplimab', 'Dosing Regimen 2 (Phase 1b): M1774 + Cemiplimab', 'Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b', 'Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b', 'Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b']}, {'name': 'Cemiplimab', 'type': 'DRUG', '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.', 'armGroupLabels': ['Dosing Regimen 1 (Phase 1b): M1774 + Cemiplimab', 'Dosing Regimen 2 (Phase 1b): M1774 + Cemiplimab', 'Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b', 'Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b', 'Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Hematology and Oncology - Santa Monica', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37909', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Cancer Specialists - Biomedical Research', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Millennium Research & Clinical Development', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cancer Specialists, PC', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'city': 'Anderlecht', 'country': 'Belgium', 'facility': "Institut Jules Bordet - Department of Institut Jules Bordet'", 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'city': 'Edegem', 'country': 'Belgium', 'facility': 'UZA - Oncology', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis Hospital', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Jette', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel - UZB', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU de Liège - PARENT', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers - Hôpital Larrey - Service de Pneumologie', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Créteil', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Limoges', 'country': 'France', 'facility': "CHU Limoges - Hôpital Dupuytren - Unite d'Oncologie Thoracique et Cutanée", 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital de la Timone - CPCEM CIC - Bat F 1er étage', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Hopital Arnaud de Villeneuve - Service de Pneumologie-Addictologie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Pessac', 'country': 'France', 'facility': "Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires", 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'city': 'Saint-Herblain', 'country': 'France', 'facility': "ICO - Site René Gauducheau - Service d'Oncologie medicale", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Giessen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik und Poliklinik III', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitaetsklinikum Leipzig AoeR - Med. 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Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMD Serono Research & Development Institute, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}