Study of Durvalumab and Chemotherapy for Patients with Resectable Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of Non-Small Cell Lung Cancer (NSCLC), specifically in patients with stages II and III of the disease. The study involves the use of a medication called Durvalumab, also known by its code name MEDI4736. Durvalumab is an immunotherapy drug that helps the immune system fight cancer. The trial will also involve various chemotherapy drugs, including Cisplatin, Carboplatin, Gemcitabine, Gemcitabine Hydrochloride, Pemetrexed, Pemetrexed Disodium, Paclitaxel, Infliximab, and Mycophenolate Mofetil. These medications will be administered to patients before and after surgery to remove the cancer.

The purpose of the study is to compare the effectiveness of Durvalumab combined with chemotherapy to a placebo combined with chemotherapy. The study will assess how well the treatment works in terms of event-free survival (EFS), which means the length of time patients remain free from certain complications or events related to cancer. It will also look at the pathological complete response (pCR), which refers to the absence of cancer cells in tissue samples after treatment. Patients will receive the treatment intravenously, meaning it will be given through a vein, and the study will follow their progress over time.

Participants in the study will undergo treatment both before and after their cancer surgery. The study aims to provide valuable information on whether adding Durvalumab to the standard chemotherapy regimen can improve outcomes for patients with operable NSCLC. The trial is expected to continue until 2028, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatment.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Tests are performed to confirm the diagnosis of non-small cell lung cancer and to assess the stage of the disease.

2 pre-surgery treatment

The treatment begins with a combination of durvalumab and chemotherapy. This phase is known as neoadjuvant therapy.

Durvalumab is administered intravenously. The chemotherapy may include drugs such as cisplatin, gemcitabine, carboplatin, paclitaxel, or pemetrexed, also given intravenously.

The duration and frequency of this treatment depend on the specific protocol of the study.

3 surgery

After completing the pre-surgery treatment, surgery is performed to remove the lung tumor. The type of surgery may include lobectomy, sleeve resection, or bilobectomy.

4 post-surgery treatment

Following surgery, the treatment continues with durvalumab as adjuvant therapy. This phase aims to eliminate any remaining cancer cells.

Durvalumab is administered intravenously, similar to the pre-surgery phase.

5 follow-up and monitoring

Regular follow-up visits are scheduled to monitor recovery and assess the effectiveness of the treatment.

These visits may include physical examinations, imaging tests, and laboratory tests to evaluate the patient’s health status and detect any signs of cancer recurrence.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Must have a lung function test result called FEV of 1.0 L or more, and more than 40% of the expected value after surgery. FEV is a test that measures how much air you can blow out of your lungs.
  • Must have been newly diagnosed and not previously treated for a type of lung cancer called Non-small Cell Lung Cancer (NSCLC) that can be surgically removed. The cancer should be in stages IIA to IIIB.
  • Must have a World Health Organization (WHO)/ECOG Performance Status of 0 or 1. This is a scale that measures how well you can perform daily activities.
  • Must have at least one tumor that has not been treated with radiation and qualifies as a RECIST 1.1 Target Lesion at the start of the study. This means the tumor can be measured to see if it changes during the study.
  • Must not have had any previous treatment with immune-based therapies, such as certain antibodies or cancer vaccines.
  • Must have adequate organ and bone marrow function. This means your organs and bone marrow are working well enough to participate in the study.
  • Must have confirmation of the tumor’s PD-L1 status. PD-L1 is a protein that can affect how the immune system responds to cancer.
  • Must provide a sufficient sample of the tumor for testing to confirm EGFR and ALK status. These are specific genes that can affect cancer growth.
  • Must have planned surgery that includes lobectomy, sleeve resection, or bilobectomy. These are types of surgeries to remove parts of the lung.

Who Cannot Join the Study?

  • Patients with other types of lung cancer that are not classified as Non-small Cell Lung Cancer.
  • Patients with lung cancer that is not in Stage IIA to IIIB. This means the cancer must be in a specific range of stages to participate.
  • Patients who have already had surgery to remove their lung cancer.
  • Patients who are not able to have surgery for their lung cancer.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are not willing to use effective birth control during the study.
  • Patients who have participated in another clinical trial recently.
  • Patients who have had an allergic reaction to similar medications in the past.
  • Patients who are unable to follow the study procedures or attend the required visits.

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
Istituto Oncologico Veneto Padua Italy
Centre Antoine Lacassagne Nice France
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Az Maria Middelares Gent Gent Belgium
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Centre Hospitalier D Avignon Avignon France
Hospital Universitario Central De Asturias Oviedo Spain
Hospital General Universitario De Alicante Alicante Spain
HIA Sainte Anne Toulon France
Matrai Gyogyintezet Gyongyos Hungary
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Degli Studi Di Verona Verona Italy
Hospital Clinic De Barcelona Barcelona Spain
Evangelisches Klinikum Bethel gGmbH Bielefeld Germany
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Kliniken der Stadt Koeln gGmbH Cologne Germany
Hopitaux Prives De Metz Vantoux France
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
CHU Helora La Louviere Belgium
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Klinikverbund Allgaeu gGmbH Kempten (Allgau) Germany
Agaplesion Frankfurter Diakonie Kliniken gGmbH Frankfurt Germany
Ryprvijsd Ztsyevywre Sqmavaqar Arnhem The Netherlands
Lrw Fqxgauoci Ilcyyb E ax Lep Rewlkakz Rankweil Austria
Hkqizhsg Ujpscdklqzppt Rxdjbbvf Dj Myqopr Malaga Spain
Mqwpqyz Usfmskbouj Oh Gdjr Graz Austria
Genqccbvofslyvyvo Vzfqffevi Pdqp Aoeyqk Edpxdmuk Oeredc Kceaut Gyor Hungary
Htkfbept Ulxljqxrwanuc Dwwqillj Donostia / San Sebastian Spain
Ntophqva Ihhoruci Ovlambnsh Igl Mbgaf Solwnjpkkjcietgnatrygkmzindn Ikqrcxcg Bglwmxop Cracow Poland
Arigrlp Ohmhdjhoibj Pfbx Gtebczsy Xirgc Bergamo Italy

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
07.07.2024
Belgium Belgium
Not recruiting
07.07.2024
France France
Not recruiting
07.07.2024
Germany Germany
Not recruiting
07.07.2024
Hungary Hungary
Not recruiting
07.07.2024
Italy Italy
Not recruiting
07.07.2024
Poland Poland
Not recruiting
07.07.2024
Spain Spain
Not recruiting
07.07.2024
The Netherlands The Netherlands
Not recruiting
07.07.2024

Trial locations

Durvalumab is a medication used in this clinical trial to help treat patients with certain types of lung cancer. It is given to patients before and after surgery to see if it can improve the chances of the cancer not coming back. Durvalumab works by helping the immune system recognize and attack cancer cells more effectively.

Chemotherapy is a treatment that uses special drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is given to patients before surgery to help shrink the tumor and make it easier to remove. The goal is to see if combining chemotherapy with durvalumab can improve treatment outcomes for patients with lung cancer.

Investigated diseases:

Non-small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as squamous cell carcinoma and adenocarcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. The disease is staged from I to IV, with stages IIA to IIIB indicating that the cancer is locally advanced but may still be resectable, meaning it can potentially be removed through surgery. As the disease progresses, it can spread to nearby lymph nodes and other parts of the body. Symptoms may include persistent cough, chest pain, and difficulty breathing. Early detection and intervention are crucial for managing the disease effectively.

Trial ID:
2023-509576-42-00
Protocol code:
D9106C00001
NCT ID:
NCT03800134
Trial Phase:
Therapeutic confirmatory (Phase III)

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