Study on the Effects of Adding Durvalumab After Chemotherapy and Surgery in 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 effects of adding a medication called durvalumab after initial treatment in patients with early-stage, operable non-small cell lung cancer (NSCLC). The study aims to understand if this additional treatment can improve the time patients remain free from cancer after surgery. The initial treatment involves a combination of chemotherapy and durvalumab, followed by surgery to remove the cancer.

Participants in the study will receive treatments through an intravenous infusion, which means the medication is given directly into a vein. The medications used in the study include cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, which are all types of chemotherapy drugs. These drugs work by targeting and killing cancer cells. The study will also use durvalumab, an immunotherapy drug that helps the immune system recognize and attack cancer cells.

The study will take place over a period of time, with participants receiving treatment for up to 16 weeks. The goal is to determine if adding durvalumab after the initial treatment can help prevent the cancer from returning. Participants will be monitored throughout the study to assess their response to the treatment and any side effects they may experience. The study is designed to provide valuable information on improving treatment outcomes for patients with early-stage NSCLC.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as confirmed non-small cell lung cancer (NSCLC), resectable and operable primary tumor, and adequate organ function.

The patient must be fit to receive platinum-based chemotherapy and have a known PD-L1 status without certain genetic mutations.

2 neoadjuvant treatment phase

The patient receives a combination of chemotherapy and immunotherapy before surgery. This includes drugs like cisplatin, carboplatin, gemcitabine hydrochloride, and durvalumab administered through intravenous infusion.

The goal is to reduce the tumor size and improve surgical outcomes.

3 surgery

After the neoadjuvant treatment, surgery is performed to remove the tumor.

The surgical outcome is assessed to determine if the tumor has been completely removed.

4 randomisation

Following surgery, patients are evaluated for randomisation based on their response to the initial treatment.

Patients are then randomly assigned to receive either additional treatment or standard follow-up care.

5 adjuvant treatment phase

Patients who are selected for additional treatment receive durvalumab as an adjuvant therapy to help prevent cancer recurrence.

This phase aims to improve disease-free survival and overall survival rates.

6 follow-up

Regular follow-up visits are scheduled to monitor the patient’s health and response to treatment.

The study tracks outcomes such as disease-free survival, overall survival, and any side effects experienced.

Who Can Join the Study?

  • The patient must have a type of lung cancer called non-small cell lung cancer (NSCLC), confirmed by a test called a histology.
  • The main tumor must be able to be removed by surgery and the patient must be healthy enough for the surgery, as decided by a team of doctors.
  • The patient must be able to receive a specific type of chemotherapy that includes a drug called platinum, according to local medical standards.
  • The cancer must be at a specific stage, called Stage IIB-IIIB, based on a system that measures the size and spread of the cancer. For Stage III, certain lymph nodes must be checked to ensure the cancer has not spread too far.
  • The patient must have a known status of a protein called PD-L1, determined by a local test.
  • The patient must not have certain genetic changes in the cancer, specifically no EGFR mutation or ALK translocation, as tested locally.
  • The patient must have normal blood, kidney, and liver function.
  • The patient must have a performance status of 0-1 on a scale called the Eastern Cooperative Oncology Group (ECOG), which measures how well the patient can perform daily activities.
  • The patient must be at least 18 years old at the time of joining the study.
  • The patient must weigh more than 30 kilograms.
  • The patient must have a life expectancy of at least 12 weeks.

Who Cannot Join the Study?

  • Patients with other types of cancer that are not the specific type being studied, which is a certain stage of lung cancer.
  • Patients who have had a different type of treatment that is not part of the study plan.
  • Patients with serious health conditions that might make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study might affect the baby.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have participated in another clinical trial recently, which might interfere with this study.
  • Patients with allergies or reactions to the study medications or similar drugs.
  • Patients with certain infections that could affect their health during the study.
  • Patients with a history of drug or alcohol abuse that might affect their ability to participate.
  • Patients who have had an organ transplant, as their immune system might be affected.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Institut Jules Bordet Anderlecht Belgium
Hospital Santa Maria Della Misericordia Perugia Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Universita’ Degli Studi Di Verona Verona Italy
Centre Hospitalier Le Mans Le Mans France
Netherlands Cancer Institute Amsterdam The Netherlands
North Estonia Medical Centre Foundation Tallin Estonia
Beaumont Hospital Dublin Ireland
Cybwef Lzlc Bzeknz Lyon France
Icqrzz Ivgbrswt Fcfyqeforysgh Ohmbwizgvfj Rome Italy
Aaxiocd Ozsnwzzgiqf Ushtzonoigdmh Scssuz Siena Italy
Ayoozgc Osgxbzjyfec Ncskltuxv Sx Ahpnvrf E Btjale E C Acleus Agzouwjdbbn Alexandria Italy
Uowximqmjr Os Aigtgqy Edegem Belgium
Ckbcdc Hleaqtqjrwp Rvgpourl Dicauhimdcnlne Angers France

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.10.2024
Belgium Belgium
Recruiting
01.10.2024
Estonia Estonia
Recruiting
01.10.2024
France France
Recruiting
01.10.2024
Ireland Ireland
Recruiting
01.10.2024
Italy Italy
Recruiting
01.10.2024
The Netherlands The Netherlands
Not yet recruiting
01.10.2024

Trial locations

Durvalumab is an immunotherapy medication used in this clinical trial. It is designed to help the body’s immune system recognize and attack cancer cells more effectively. In this study, durvalumab is given to patients after they have received initial treatment with chemotherapy and durvalumab, to see if it can improve the time patients remain free from cancer.

Stage IIB-IIIB (N2) Resectable Non-Small Cell Lung Cancer – This is a type of lung cancer that is categorized by its ability to be surgically removed and its specific stage of progression. In Stage IIB, the cancer has spread to nearby lymph nodes or structures, while Stage IIIB indicates further spread to lymph nodes on the opposite side of the chest or above the collarbone. The term “N2” refers to the involvement of lymph nodes in the center of the chest, which can complicate surgical removal. This cancer type is known for its potential to grow and spread to other parts of the body if not treated. The progression of the disease can vary, with some patients experiencing more rapid advancement than others.

Trial ID:
2023-508773-82-00
Protocol code:
ETOP25-23 ADOPT-lung
NCT ID:
NCT06284317
Trial Phase:
Therapeutic confirmatory (Phase III)

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