Study on Durvalumab and Domvanalimab 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 a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC), specifically in patients with advanced stages of the disease that cannot be surgically removed. The study is investigating the effects of a combination of two medications, Durvalumab and Domvanalimab (also known by the code name AB154), compared to Durvalumab with a placebo. Durvalumab is a medication that helps the immune system fight cancer, and Domvanalimab is a type of antibody that targets specific proteins in the body to help control the cancer. The purpose of the study is to see if the combination of these two medications is more effective than using Durvalumab alone.

Participants in this study are those whose cancer has not worsened after receiving a specific type of treatment called chemoradiation therapy, which combines chemotherapy and radiation. The study will involve regular monitoring of the participants’ health and the progression of their cancer over a period of time. The treatment will be administered through an infusion, which means the medication is given directly into the bloodstream through a vein. The study aims to determine if the combination of Durvalumab and Domvanalimab can help improve the time patients live without their cancer getting worse.

Throughout the study, participants will receive either the combination of Durvalumab and Domvanalimab or Durvalumab with a placebo. The study will last for a set period, during which participants will be closely monitored by healthcare professionals. The goal is to gather information on how well the treatment works and its safety. This research could potentially lead to new treatment options for patients with advanced NSCLC, providing hope for better management of this challenging condition.

1 joining the study

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

Participants must have a confirmed diagnosis of locally advanced, unresectable non-small cell lung cancer (NSCLC) and have completed concurrent chemoradiation therapy (cCRT) without disease progression.

2 randomization

Participants are randomly assigned to receive either the combination of durvalumab and domvanalimab or durvalumab and a placebo.

This process ensures that the study results are unbiased and scientifically valid.

3 treatment administration

The treatment involves the administration of durvalumab and domvanalimab or durvalumab and a placebo through intravenous infusion.

The specific dosage and frequency of administration are determined by the study protocol and are monitored by healthcare professionals.

4 monitoring and assessments

Participants undergo regular monitoring to assess the progression of the disease and the effectiveness of the treatment.

Assessments include imaging studies and other tests as specified in the study protocol.

5 follow-up

Participants continue to be monitored for progression-free survival (PFS) and overall survival (OS) as part of the study’s primary and secondary endpoints.

Follow-up assessments are conducted at regular intervals to evaluate the long-term effects of the treatment.

Who Can Join the Study?

  • Participants must be at least 18 years old at the time of screening.
  • Participants must have a type of lung cancer called NSCLC (non-small cell lung cancer) that has been confirmed through tests.
  • Participants must have been treated with a combination of chemotherapy and radiation for lung cancer that is advanced and cannot be removed by surgery.
  • Participants must provide a sample of their tumor tissue that was taken before they received chemotherapy and radiation.
  • The tumor must show a PD-L1 status of 1% or higher, which is determined by a central laboratory. PD-L1 is a protein that can be found on cancer cells.
  • The tumor must not have certain genetic changes known as EGFR and ALK mutations.
  • Participants must not have experienced worsening of their cancer after receiving a specific type of chemotherapy and radiation.
  • Participants must have received at least two cycles of chemotherapy that includes a drug called platinum, along with radiation therapy.
  • Participants must have received a specific amount of radiation, between 54 and 66 units (called Gy), as part of their treatment.
  • Participants must have a WHO performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • Participants must have organs and bone marrow that are functioning well enough to participate in the study.

Who Cannot Join the Study?

  • Participants with a different type of cancer than the one being studied.
  • Participants whose cancer has spread to other parts of the body.
  • Participants who have had surgery to remove their lung cancer.
  • Participants whose tumors do not show a certain level of a protein called PD-L1.
  • Participants who have not received a specific type of chemotherapy called platinum-based cCRT.
  • Participants whose cancer has worsened after receiving the specific chemotherapy.
  • Participants who are under the age of 18.
  • Participants who are unable to give informed consent.
  • Participants who are pregnant or breastfeeding.
  • Participants with other serious health conditions that could interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
Reseau De Sante Mutualiste Villeurbanne France
Centre Jean Perrin Clermont Ferrand France
IRCCS Humanitas Research Hospital Rozzano Italy
Koranyi National Institute For Pulmonology Budapest Hungary
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Sigmedical Services S.R.L. Suceava Romania
Orszagos Onkologiai Intezet Budapest Hungary
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Staedtisches Klinikum Braunschweig gGmbH Brunswick Germany
HELIOS Klinikum Krefeld GmbH Krefeld Germany
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Centre Hospitalier Regional De La Citadelle Liege Belgium
St. Olavs Hospital HF Trondheim Norway
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
Vitaz Sint-Niklaas Belgium
Radiotherapy Center Cluj S.R.L. Floresti Romania
Hospital Universitario Basurto Bilbao Spain
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
Consorcio Hospitalario Provincial De Castellon Castello De La Plana Spain
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Nordlandssykehuset HF Bodo Norway
Pelican Impex S.R.L. Oradea Romania
Henry Dunant Hospital Center Athens Greece
Chirec Brussels Belgium
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Regensburg Germany
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis Aix En Provence France
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Hôpital Avicenne Bobigny France
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Institutul Regional De Oncologie Iasi Iasi Romania
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Katholisches Klinikum Koblenz Montabaur gGmbH Koblenz Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Kliniken der Stadt Koeln gGmbH Cologne Germany
Oncocenter Oncologie Clinica S.R.L. Timisoara Romania
Justus-Liebig-Universitaet Giessen Giessen Germany
Hopitaux Prives De Metz Vantoux France
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Centre Hospitalier De Saint-Quentin Saint Quentin France
Spitalul Clinic Judetean De Urgenta Sibiu Sibiu Romania
St. Luke’s Hospital S.A. Thessaloniki Greece
CHU Helora La Louviere Belgium
Sykehuset Innlandet HF Brumunddal Norway
Servei De Salut De Les Illes Balears Palma Spain
University Of Szeged Szeged Hungary
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Hospitalier De Pau Pau France
Metropolitan Hospital Athens Greece
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Agxenmz Okdzomjdccg Pjvk Gjqxetct Xiloe Bergamo Italy
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Iaygnx Icypsbei Febedcsnknsix Oghkooeehmi Rome Italy
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Daodrgvlvtao Cybaibh Ogzdzjvgr Prvhnuvelwvd I Howiamecrum Wroclaw Poland
Denxmx Mrllyxrr Bdibgnrzai Sywgkqslpnx Deszk Hungary
Nmwkuh Vbzzxduzb Seetj Lduzz Kinhhg Salgotarjan Hungary
Pfdd Torai Hewwuwvb Uteblgguompw Sabadell Spain
Lssfc Gfsaexz Hfgbesjc Ol Aogplr Athens Greece
Geowacpxdvikctjzq Vknzwgqdg Pnfc Ahdgnk Etgbhhrk Ofuzmv Ksqyge Gyor Hungary
Adbisg Muaqnyt Cuxenv Sryt Thessaloniki Greece
Nldouapz Igoqkrsq Oelaeayga Igz Mxnux Swojiophjcmejaklvtpoauhwbbpx Iyztchgi Blsthizh Cracow Poland
Urqjuzbgdl Oc Avljylb Edegem Belgium
Gmsddz Hivfyafosuu Uqspyiotwtvee Pglml Pnobfhzqyhu Eu Nyaajksjdose Paris France
Kaloqfhjuc Cykfytm Olvxzcipk Katowice Poland
Cwiuse Ootzg Lxiihis Lille France
Urzxifcxql Gapivmm Hvrdpmqs Aboytbs Athens Greece

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
14.11.2023
France France
Recruiting
14.11.2023
Germany Germany
Recruiting
14.11.2023
Greece Greece
Recruiting
14.11.2023
Hungary Hungary
Recruiting
14.11.2023
Italy Italy
Recruiting
14.11.2023
Norway Norway
Recruiting
14.11.2023
Poland Poland
Recruiting
14.11.2023
Romania Romania
Recruiting
14.11.2023
Spain Spain
Recruiting
14.11.2023

Trial locations

Durvalumab is a medication used in this trial to help the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the immune system to better target and destroy them. This medication is being tested to see if it can improve outcomes for patients with a specific type of lung cancer that has not progressed after initial treatment.

Domvanalimab (AB154) is another medication being studied in this trial. It is designed to enhance the body’s immune response against cancer cells. By targeting certain pathways in the immune system, it aims to boost the ability of immune cells to recognize and attack cancer cells. This medication is being combined with durvalumab to see if the combination is more effective than durvalumab alone in treating lung cancer.

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 characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. NSCLC is often diagnosed at an advanced stage, where the cancer has spread locally but cannot be surgically removed. The progression of NSCLC can vary, but it typically involves the growth and spread of cancer cells to nearby tissues and possibly to other parts of the body. The expression of certain proteins, like PD-L1, can influence the behavior of the cancer and its response to treatments.

Trial ID:
2023-506891-28-00
Protocol code:
D9075C00001
NCT ID:
NCT05211895
Trial Phase:
Therapeutic confirmatory (Phase III)

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