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ACTIVE NOT RECRUITING Phase 1

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

NCT05882734 · View on ClinicalTrials.gov ↗

Study 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..

Conditions Studied

Interventions

  • DRUG Cemiplimab
  • DRUG M1774

Study Locations (20)

Other

  • 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

Texas

  • The University of Texas MD Anderson Cancer Center — Houston
  • Millennium Research & Clinical Development — Houston

California

  • UCLA Hematology and Oncology - Santa Monica — Santa Monica

Pennsylvania

  • UPMC Cancer Center — Pittsburgh

Tennessee

  • Tennessee Cancer Specialists - Biomedical Research — Knoxville

Virginia

  • Virginia Cancer Specialists, PC — Fairfax

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2023-09-13
Est. Completion 2026-03-30
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05882734

The ClinicalTrials.gov registry entry for NCT05882734 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions — of which Cemiplimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05882734 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05882734 about?

NCT05882734 is a clinical study titled "Tuvusertib (M1774) in Combination With Cemiplimab in Participants With Non-Squamous NSCLC (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-Squa...

What is the current status of trial NCT05882734?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2023-09-13. Estimated completion is 2026-03-30.

What conditions does trial NCT05882734 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05882734?

The interventions under investigation include: Cemiplimab (DRUG), M1774 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05882734?

This trial is sponsored by EMD Serono Research & Development Institute, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05882734 being conducted?

This trial has 20 study locations across California, Pennsylvania, Tennessee, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial