Study on Durvalumab with Oleclumab or Monalizumab for Patients with Stage III Unresectable Non-Small Cell Lung Cancer After Chemoradiation Therapy

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What is this study about?

This clinical trial is focused on studying treatments for patients with Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC). The study will explore the effects of combining the medication Durvalumab with either Oleclumab or Monalizumab. Durvalumab is a type of medication known as an immunotherapy, which helps the immune system fight cancer. Oleclumab and Monalizumab are also immunotherapies that work in different ways to support the immune system in targeting cancer cells.

The purpose of this study is to determine if the combination of Durvalumab with Oleclumab or Monalizumab is more effective than Durvalumab with a placebo in treating patients who have not experienced cancer progression after receiving a specific type of treatment called platinum-based concurrent chemoradiation therapy. This therapy involves using chemotherapy and radiation at the same time to treat cancer. The study will involve participants receiving these treatments through intravenous infusions, which means the medication is given directly into a vein.

Participants in the study will be monitored over a period of time to assess the effectiveness of the treatments. The study aims to provide valuable information on whether these combinations can improve outcomes for patients with this type of lung cancer. The trial will be conducted in a way that ensures the safety and well-being of all participants, with regular check-ups and assessments throughout the study period.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical history, and previous treatments.

A tumor tissue sample is required, and the status of certain proteins and genes in the tumor is documented.

2 randomization

Participants are randomly assigned to one of the treatment groups: durvalumab with oleclumab, durvalumab with monalizumab, or durvalumab with a placebo.

3 treatment administration

Durvalumab is administered as an intravenous infusion. The dosage is 50 mg/mL, and the frequency and duration are determined by the study protocol.

Oleclumab and monalizumab are also administered intravenously, with specific dosages and schedules provided during the study.

4 monitoring and assessments

Regular monitoring is conducted to assess the progression of the disease and the response to treatment.

Progression-free survival is evaluated using specific criteria over a period of up to five years.

5 completion of the study

The study is estimated to conclude by May 31, 2030, with ongoing assessments and data collection until that time.

Who Can Join the Study?

  • The participant must be at least 18 years old at the time of screening.
  • The participant must have a confirmed diagnosis of non-small cell lung cancer (NSCLC), which is a type of lung cancer, and must have been treated with concurrent chemoradiotherapy (CRT) for locally advanced, unresectable (Stage III) disease. Concurrent chemoradiotherapy means receiving chemotherapy and radiation therapy at the same time.
  • A sample of the tumor tissue must be provided, which was obtained before the CRT treatment.
  • The tumor must have a documented PD-L1 status. PD-L1 is a protein that can affect the immune system’s ability to fight cancer.
  • The tumor must be documented as EGFR and ALK wild-type. This means the cancer does not have certain genetic mutations that are sometimes found in lung cancer.
  • The participant must not have experienced disease progression after receiving a definitive, platinum-based, concurrent chemoradiotherapy. Platinum-based chemotherapy is a common type of cancer treatment that uses drugs containing platinum.
  • The participant must have received at least 2 cycles of platinum-based chemotherapy along with radiation therapy.
  • The participant must have received a total radiation dose of 60 Gy, with a possible variation of 10% (between 54 Gy and 66 Gy), as part of the chemoradiation therapy. Gy stands for Gray, a unit of radiation dose. The radiation should be given using intensity modulated radiation therapy (IMRT), which is preferred, or a 3D-conforming technique.
  • The participant must have a WHO performance status of 0 or 1 at the time of randomization. This is a scale that measures the participant’s general well-being and ability to carry out daily activities, where 0 means fully active and 1 means some restrictions but still able to do light work.
  • The participant must have adequate organ and bone marrow function, which means their organs and bone marrow are working well enough to handle the treatment.

Who Cannot Join the Study?

  • Patients who have had surgery to remove their lung cancer.
  • Patients whose lung cancer has spread to other parts of the body.
  • Patients who have not received prior treatment with platinum-based chemotherapy and radiation therapy.
  • Patients who have experienced progression of their lung cancer after receiving platinum-based chemotherapy and radiation therapy.
  • Patients with other types of cancer that are not lung cancer.
  • Patients with serious heart conditions or uncontrolled high blood pressure.
  • Patients with active infections that require treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Franziskus Hospital Harderberg Georgsmarienhütte Germany
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Centre Hospitalier Universitaire Rouen Rouen France
Onkodok GmbH Guetersloh Germany
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
CHU Gabriel-Montpied Clermont Ferrand France
Klinikum Region Hannover GmbH Hanover Germany
HELIOS Klinikum Erfurt GmbH Erfurt Germany
Hospital Del Mar Barcelona Spain
Unidade Local De Saude De Loures-Odivelas EPE Loures Portugal
Hospital Cuf Descobertas S.A. Lisbon Portugal
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o. Tomaszow Mazowiecki Poland
Universitaetsklinikum Erlangen AöR Erlangen Germany
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Champalimaud Clinical Centre Lisbon Portugal
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Universidade De Santiago De Compostela Santiago De Compostela Spain
Groupe Hospitalier Bretagne Sud Lorient France
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Universita Degli Studi Di Brescia Brescia Italy
Institut Sainte Catherine Avignon France
CHU Bordeauxt Bordeaux France
Hôpital Pontchaillou-CHU Rennes Rennes France
Ieyysqtv Rtlywotg Dr Cfyjrx Dx Mistujrmwzl Montpellier France
Akxpans Oblypcvcnzp Uhshzoogggtbc Peqnn Parma Italy
Uvshxbdfbintwvwnxozwe Extyk Aiz Essen Germany
Atkxxrk Uht Tfbjrld nosa oerlx Leghorn Italy
Izyehwdz Rdmqscjcr Poa Lj Sfrxkr Dsi Tzsbge Dxia Axdblvz Isuk Smoyyz Meldola Italy
Auzaeukbza Prtalhsu Hxieeied Dd Mryectfrj Marseille France
Bqggtvtp Uksoguytdj Hhenvmun Cjnulp Besançon France
Ntoevlmm Irqvdnoh Ouxtysdyp Imo Mijnh Shkcwoyttpgbryxbuozuavtdwgyo Iiozazvz Bhktmamz Cracow Poland
Ujbauhhuzbiziarnyezlu Whbiwpyvs Axe Wuerzburg Germany
Grge Sklbw Pdnjumbpx Cpjymsf Sxmq Cascais Portugal
Uxsmlosuddwtqo Czdtgqs Kkwtthgtx Gdansk Poland
Hxdehjxo Vpjw dkbvzndq Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
28.01.2024
Germany Germany
Not recruiting
28.01.2024
Italy Italy
Not recruiting
28.01.2024
Poland Poland
Not recruiting
28.01.2024
Portugal Portugal
Not recruiting
28.01.2024
Spain Spain
Not recruiting
28.01.2024

Trial locations

Durvalumab is a medication used to help the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells. In this trial, it is used to treat patients with a type of lung cancer that cannot be removed by surgery.

Oleclumab is an experimental drug that is being studied to see if it can help the immune system work better against cancer. It is used in combination with durvalumab to see if it can improve the treatment of lung cancer.

Monalizumab is another experimental drug that is being tested to see if it can enhance the immune system’s ability to fight cancer. It is also used with durvalumab in this trial to evaluate its effectiveness in treating lung cancer.

Investigated diseases:

Non-small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. In its locally advanced stage (Stage III), the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body. When the cancer is unresectable, it means it cannot be removed completely through surgery. The progression of NSCLC can vary, but it often involves the gradual worsening of symptoms such as coughing, chest pain, and difficulty breathing.

Trial ID:
2023-503999-24-00
Protocol code:
D9078C00001
Trial Phase:
Therapeutic confirmatory (Phase III)

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