Study of Tuvusertib and Cemiplimab for Patients with Non-Squamous Non-Small Cell Lung Cancer After Previous Treatments

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Non-Squamous Non-Small Cell Lung Cancer (NSCLC). The study is testing a combination of two treatments: Tuvusertib (also known by its code name M1774) and Cemiplimab. Tuvusertib is a new medication being tested in capsule form, while Cemiplimab is given as a solution for infusion. The purpose of the study is to evaluate how effective and safe these treatments are when used together in patients whose cancer has progressed despite previous treatments.

Participants in the study will receive the combination of Tuvusertib and Cemiplimab. The study is divided into two phases. In the first phase, researchers will focus on finding the best dose of Tuvusertib to use with Cemiplimab. In the second phase, they will look at how well the combination works in treating the cancer. Throughout the study, researchers will monitor participants for any side effects and how well the cancer responds to the treatment.

The study will involve regular check-ups and assessments to track the progress of the treatment. Participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on the effectiveness of the treatment. The study aims to provide valuable insights into the potential benefits of combining Tuvusertib and Cemiplimab for treating Non-Squamous Non-Small Cell Lung Cancer.

1 joining the study

Upon joining the study, participation begins with an initial assessment to confirm eligibility. This includes a review of medical history and current health status.

Eligibility criteria include being 18 years or older, having a confirmed diagnosis of non-squamous non-small cell lung cancer, and having experienced disease progression after specific prior treatments.

2 phase 1b treatment

The first phase involves receiving a combination of two medications: cemiplimab and Tuvusertib (M1774). Cemiplimab is administered as a solution for infusion, while Tuvusertib is taken orally in the form of hard capsules.

The purpose of this phase is to evaluate the safety and effectiveness of the treatment combination and to determine the appropriate dosage for the next phase.

3 monitoring and assessment

Throughout the treatment, regular monitoring is conducted to assess the response to the medication and to identify any side effects. This includes physical examinations, imaging tests, and laboratory tests.

The primary focus is on measuring the overall response to the treatment and identifying any adverse events.

4 phase 2a treatment

In the second phase, the treatment continues with the same combination of cemiplimab and Tuvusertib, using the dosage regimen determined in phase 1b.

This phase aims to further assess the effectiveness of the treatment in terms of response duration and survival rates.

5 ongoing evaluation

Participants continue to be evaluated for treatment response and any side effects. This includes ongoing assessments of disease progression and overall survival.

The study is expected to continue until October 2025, with regular follow-ups to monitor long-term outcomes.

Who Can Join the Study?

Must be 18 years or older at the time of signing the consent form.
Must have a diagnosis of Non-Squamous Non-Small Cell Lung Cancer confirmed by a doctor.
Must have proof of disease getting worse during or after certain treatments:
- Only one previous treatment with a type of medicine called anti-PD-(L)1 for advanced cancer.
- Must have had platinum-based therapy for advanced cancer, either with or after anti-PD-(L)1 therapy. If this treatment was given before surgery or to shrink the tumor, the disease must have worsened within 6 months after the last dose.
- Must have had a response of stable disease or better with anti-PD-(L)1 therapy.
- The disease must have worsened while on anti-PD-(L)1 therapy or within 16 weeks after the last dose.
Must have a measurable disease as determined by the doctor using specific guidelines.
Must have an ECOG Performance Status of 0 or 1, which means the patient is fully active or has some symptoms but can still do light work.
Must have adequate blood, liver, and kidney function as defined in the study protocol.
Must have available tumor tissue samples or have had a specific genetic test done in a certified lab, and the PD-L1 status must be known.
For the Phase 2a part only: Must have a liquid biopsy to check for specific tumor changes, and participants will be placed in different groups based on the results.
Other criteria defined in the study protocol may also apply.

Who Cannot Join the Study?

Patients with other types of cancer besides Non-Squamous Non-Small Cell Lung Cancer cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to follow the study procedures or take the study medications cannot participate.
Patients with certain medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients with a history of severe allergic reactions to the study medications cannot participate.
Patients with uncontrolled medical conditions that could affect their safety during the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Centre Hospitalier Intercommunal Creteil	Creteil	France
Universitaetsmedizin Goettingen	Goettingen	Germany
Universitaet Leipzig	Leipzig	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Universitario Virgen De Valme	Sevilla	Spain
Institut Jules Bordet	Anderlecht	Belgium
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Jessa Ziekenhuis	Hasselt	Belgium
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hopital Beaujon	Clichy	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Vrije Universiteit Brussel	Jette	Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Sana Klinikum Offenbach GmbH	Offenbach Am Main	Germany
Institut De Cancerologie De L Ouest	Saint-Herblain	France
Cvycby Hoxdvhugcyj Ea Ussnruuabqtvm Dp Lhohkvo	Limoges	France
Aathjxhump Pbhcifqx Hsnnkcfu Dq Mugomawrp	Marseille	France
Ayylmrc Omzfptmigbe Uufawwlfmcxxe Svqntw	Siena	Italy
Aqffaul Uxrvj Stmszgmey Lmmndv Dk Bcpehdm	Bologna	Italy
Unhslxcqoq Os Aodqbpr	Edegem	Belgium
Ibpfro Ivkhgwyo Ffeipdfmkblix Ochvltxijpr	Rome	Italy
Ccamsf Hryylqytajl Rumwxuoz Ddksrztzlotnkb	Angers	France
Frkkmzwyk Pgsb Lt Iwroagdoznoet Bsmljzhcb Dht Hmvowqsc Uznzvswhwawmd Ls Pov	Madrid	Spain
Hgmmlcyc Urifjhqbztbex Hfwkqrio Twxiy y Pigbsr Iezwkrez Cgdjqv dvajgjvqktqgjpeqm (bdmv	Badalona	Spain
Hevuomzg Vnaj dmesesoi	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	31.10.2023
France	Not recruiting	31.10.2023
Germany	Not recruiting	31.10.2023
Italy	Not recruiting	31.10.2023
Spain	Not recruiting	31.10.2023

Trial locations

Investigated drugs:

Tuvusertib (M1774) is an experimental medication being studied for its potential to treat non-squamous non-small cell lung cancer. It works by inhibiting a specific protein called ATR, which is involved in the repair of damaged DNA in cancer cells. By blocking this protein, Tuvusertib may help to prevent cancer cells from repairing themselves, potentially leading to their death and slowing the progression of the cancer.

Cemiplimab is a medication used in cancer treatment that helps the immune system recognize and attack cancer cells. It is a type of immunotherapy known as a PD-1 inhibitor. By blocking the PD-1 pathway, cemiplimab can enhance the body’s immune response against cancer cells, which may help to slow down or stop the growth of the cancer.

Investigated diseases:

Non-small cell lung cancer

Non-Squamous Non-Small Cell Lung Cancer – This is a type of lung cancer that originates in the tissues of the lung, specifically in cells that are not squamous in nature. It is one of the most common types of lung cancer and includes subtypes such as adenocarcinoma and large cell carcinoma. The disease typically begins in the outer parts of the lungs and may not cause symptoms until it has progressed. As it advances, it can spread to other parts of the body, including the lymph nodes and other organs. Symptoms may include a persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some cases growing slowly while others may advance more rapidly.

Trial ID:

2022-502010-85-00

Protocol code:

MS201924_0022

NCT ID:

NCT05882734

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Tuvusertib and Cemiplimab for Patients with Non-Squamous Non-Small Cell Lung Cancer After Previous Treatments

What is this study about?

Who Can Join the Study?

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