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Experimental combo targets Hard-to-Treat lung cancer

NCT ID NCT05882734

Disease control Sponsor: EMD Serono Research & Development Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This study tests a new drug, Tuvusertib, combined with an immunotherapy called Cemiplimab in people with a specific type of advanced lung cancer (non-squamous non-small cell) that has worsened after prior treatments. The trial aims to see if the combination can shrink tumors and how safe it is. About 61 participants will receive the drugs until their disease progresses or side effects become too severe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tuvusertib (M1774) and Cemiplimab
What this could lead to
If successful, this combination could offer a new treatment option for people with a type of lung cancer that has stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with only 61 participants, so results may not apply broadly. The combination may cause significant side effects or fail to improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

61 people

The number who actually took part.

Started

Sep 2023

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hereditary sensory and autonomic neuropathy non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Nagoya, Japan

  • Asan Medical Center

    Seoul, South Korea

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

    Bologna, Italy

  • CHU Angers - Hôpital Larrey - Service de Pneumologie

    Angers, France

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

    Limoges, France

  • CHU de Liège - PARENT

    Liège, Belgium

  • Cancer Institute Hospital of JFCR

    Kōtoku, Japan

  • Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie

    Créteil, France

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

    Rome, Italy

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

    Pessac, France

  • Hopital Arnaud de Villeneuve - Service de Pneumologie-Addictologie

    Montpellier, France

  • Hospital Clinic de Barcelona - Servicio de Oncologia

    Barcelona, Spain

  • Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

    Madrid, Spain

  • Hospital Regional Universitario de Malaga - Oncology Dept

    Málaga, Spain

  • Hospital Universitari Vall d'Hebron - Oncology Dept.

    Barcelona, Spain

  • Hospital Universitari i Politecnic La Fe - Oncology Department

    Valencia, Spain

  • Hospital Universitario 12 de Octubre - Servicio de Oncologia

    Madrid, Spain

  • Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

    Madrid, Spain

  • Hospital Universitario La Paz - Oncology Department

    Madrid, Spain

  • Hospital Universitario Nuestra Señora de Valme - Servicio de Oncologia

    Seville, Spain

  • Hospital Universitario Ramon y Cajal - Servicio de Oncologia

    Madrid, Spain

  • Hospital Universitario Reina Sofia - Dept of Oncology

    Córdoba, Spain

  • Hospital Universitario Virgen Macarena - Oncology Service

    Seville, Spain

  • Hospital Universitario Virgen del Rocio - Oncology Service

    Seville, Spain

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

    Marseille, France

  • ICO - Site René Gauducheau - Service d'Oncologie medicale

    Saint-Herblain, France

  • IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica

    Milan, Italy

  • Institut Jules Bordet - Department of Institut Jules Bordet'

    Anderlecht, Belgium

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

    Rozzano, Italy

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

    Naples, Italy

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

    Roma, Italy

  • Jessa Ziekenhuis Hospital

    Hasselt, Belgium

  • Kanagawa Cancer Center

    Yokohama, Japan

  • Kansai Medical University Hospital

    Hirakata-shi, Japan

  • Kindai University Hospital

    Osakasayama-shi, Japan

  • Kurume University Hospital

    Kurume-shi, Japan

  • Millennium Research & Clinical Development

    Houston, Texas, 77090, United States

  • National Cancer Center Hospital

    Chūōku, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Japan

  • Ospedale San Raffaele - U.O. di Oncologia Medica

    Milan, Italy

  • Samsung Medical Center

    Seoul, South Korea

  • Sana Klinikum Offenbach GmbH - Medizinische Klinik IV

    Offenbach, Germany

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

    Seoul, South Korea

  • Tennessee Cancer Specialists - Biomedical Research

    Knoxville, Tennessee, 37909, United States

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

    Seoul, South Korea

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCLA Hematology and Oncology - Santa Monica

    Santa Monica, California, 90404, United States

  • UPMC Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • UZ Leuven

    Leuven, Belgium

  • UZA - Oncology

    Edegem, Belgium

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

    Giessen, Germany

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

    Leipzig, Germany

  • Universitair Ziekenhuis Brussel - UZB

    Jette, Belgium

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.