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Non-Small Cell Lung CancerPhase 1/2NCT05882734

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

A Phase 1/2 study testing M1774 and Cemiplimab in people with Non-Small Cell Lung Cancer, run by EMD Serono Research & Development Institute, Inc. at 54 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
M1774 and Cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
54 sitesin 8 countries
Study dates
13 Sep 2023to 15 Jul 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

54 sites in 8 countries.

54 sites in 8 countries

Spain13 sites

  • 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

Other trials in Spain

Japan8 sites

  • 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

Other trials in Japan

France7 sites

  • 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

Other trials in France

Italy7 sites

  • 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

    Naples

  • 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

Other trials in Italy

United States6 sites

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Millennium Research & Clinical Development

    Houston, Texas, 77090

  • Tennessee Cancer Specialists - Biomedical Research

    Knoxville, Tennessee, 37909

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UCLA Hematology and Oncology - Santa Monica

    Santa Monica, California, 90404

Other trials in United States

Belgium6 sites

  • 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

Other trials in Belgium

South Korea4 sites

  • 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

Other trials in South Korea

Germany3 sites

  • 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

Other trials in Germany

About this study

Official title: 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)

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..

Being tested
M1774, Cemiplimab
Keywords
Ataxia telangiectasia mutated and Rad3-related protein kinase (ATR) inhibitor, Tuvusertib (M1774), Non squamous Non small cell lung cancer, Cemiplimab
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Hereditary Sensory and Autonomic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M1774Drug

    Also called Tuvusertib

    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.

  • CemiplimabDrug

    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.

Study groups in NCT05882734
Study groupRoleWhat they receive
Dosing Regimen 1 (Phase 1b): M1774 + CemiplimabExperimentalNot described
Receives: Drug: M1774; Drug: Cemiplimab
Dosing Regimen 2 (Phase 1b): M1774 + CemiplimabExperimentalNot described
Receives: Drug: M1774; Drug: Cemiplimab
Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1bExperimentalNot described
Receives: Drug: M1774; Drug: Cemiplimab
Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1bExperimentalNot described
Receives: Drug: M1774; Drug: Cemiplimab
Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1bExperimentalNot described
Receives: Drug: M1774; Drug: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b/Phase 2a: Confirmed Overall response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 As assessed by Investigator

    Measured: Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months

  2. Phase 1b: Number of Participants With Adverse Events (AEs) and Treatment-related AEs

    Measured: Time from randomization to final assessment at end of safety follow-up visit approximately up to 3 years and 2 months

Secondary outcomes (4)

  1. Phase 1b/Phase 2a: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator

    Measured: Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months

  2. Phase 1b/Phase 2a: Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator

    Measured: Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months

  3. Phase 1b/Phase 2a: Overall survival (OS)

    Measured: Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months

  4. Phase 2a: Number of Participants With AEs and Treatment-related AEs

    Measured: Time from randomization to final assessment at end of safety follow-up visit (approximately up to 3 years and 2 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2023
  2. Study start13 Sep 2023
  3. Primary completion15 Jul 2026
  4. Study completion15 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05882734
Sponsor's protocol ID
MS201924_0022
Other IDs
2022-502010-85-00, jRCT2031230332, CTR20242324
Status last verified
Sep 2026
First submitted
22 May 2023
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing M1774 and Cemiplimab in people with Non-Small Cell Lung Cancer, run by EMD Serono Research & Development Institute, Inc. at 54 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Spain, Japan, France, Italy, United States and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b/Phase 2a: Confirmed Overall response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 As assessed by Investigator (time frame: Time from randomization to final assessment or until progression disease, death, discontinuation criteria approximately up to 3 years and 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05882734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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