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Study on Durvalumab and Chemotherapy for Patients with Relapsed Stage III Non-Small Cell Lung Cancer After Chemoradiotherapy and Durvalumab Treatment

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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). The study is investigating the effects of a treatment called durvalumab, which is also known by its code name MEDI4736. Durvalumab is a medication given as a solution through an infusion, which means it is administered directly into the bloodstream. The purpose of the study is to see if durvalumab can help improve the survival of patients who have relapsed after receiving previous treatments, including chemotherapy and radiation therapy.

The study is divided into two groups, or cohorts. In the first group, researchers are looking at patients who continue to receive durvalumab along with a single chemotherapy drug to see if this combination helps them live longer. In the second group, the study is examining whether continuing durvalumab after initial treatments can improve survival in patients whose cancer has returned. The trial will follow participants over a period of time to monitor their health and any changes in their condition.

Throughout the study, researchers will collect information on how long patients live, how long they remain free from cancer progression, and how their bodies respond to the treatment. They will also monitor the safety of the treatment and any side effects that may occur. This information will help determine the effectiveness of durvalumab in treating relapsed NSCLC and provide insights into potential future treatments for this type of lung cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, weight, and health status. This includes a body weight greater than 30 kg and normal organ and bone marrow function.

A signed informed consent form is required, indicating understanding and agreement to comply with study requirements.

2 initial assessment

An initial assessment is conducted to evaluate the current health status. This includes tests to confirm the presence of non-small cell lung cancer (NSCLC) and progression during or after previous treatments.

Tumor tissue is collected for biomarker testing to help guide treatment decisions.

3 treatment phase

The treatment involves the administration of durvalumab, a medication given as a solution for infusion. This is a liquid that is slowly introduced into the bloodstream through a vein.

The study aims to evaluate the effectiveness of durvalumab in prolonging survival when combined with chemotherapy in patients who have relapsed after previous treatments.

4 monitoring and follow-up

Regular visits are scheduled to monitor health status and response to treatment. This includes checking for any side effects and assessing the progression of the disease.

The study will track overall survival and progression-free survival, which measures the time during and after treatment that the patient lives with the disease without it getting worse.

5 completion of study

The study is expected to continue until September 2026. Upon completion, final assessments are conducted to evaluate the overall outcomes of the treatment.

Participants are informed of the results and any further recommendations for their health care.

Who Can Join the Study?

  • Body weight must be more than 30 kg.
  • Normal organ and bone marrow function is required, which means:
    • Haemoglobin level should be at least 10.0 g/dL without a blood transfusion in the last 28 days.
    • Absolute neutrophil count (ANC) should be at least 1.5 x 109/L.
    • Platelet count should be at least 100 x 109/L.
    • Serum bilirubin should be no more than 1.5 times the normal limit, except for patients with Gilbert’s syndrome.
    • AST (SGOT)/ALT (SGPT) should be no more than 2.5 times the normal limit, or 5 times if liver metastases are present.
    • Creatinine clearance should be at least 51 mL/min, which is a measure of kidney function.
  • Female patients must use effective birth control or abstain from sexual intercourse during the study and for 90 days after the last dose of the study drug.
  • Women must have a negative pregnancy test before starting the study and meet certain criteria to be considered postmenopausal or not able to have children.
  • Male patients must use a condom during sexual intercourse if their partner is pregnant or can become pregnant. Female partners should also use effective birth control if they can become pregnant.
  • Patients must have recurrent or metastatic NSCLC (non-small cell lung cancer) that returned during or after treatment with chemotherapy and durvalumab for stage III disease.
  • Tumor tissue must be available for testing.
  • There must be evidence of disease progression during or after durvalumab treatment, but not within the first three months of starting durvalumab.
  • Patients must have an ECOG performance status of 0 or 1, which indicates they are fully active or have some symptoms but do not need bed rest.
  • Patients must be willing and able to follow the study protocol, including attending visits and undergoing tests.
  • Patients must be at least 18 years old.
  • Patients must be able to give informed consent, which means they understand the study and agree to participate.
  • Patients must have a life expectancy of at least 16 weeks.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than NSCLC (non-small cell lung cancer) cannot participate.
  • Patients who are not in the age range specified for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have any other medical condition that might interfere with the study or make it unsafe for them cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Azienda Unita Sanitaria Locale Di Piacenza Piacenza Italy
San Camillo Forlanini Hospital Rome Italy
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Azienda Socio Sanitaria Territoriale Di Bergamo Ovest Treviglio Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Degli Studi Di Verona Verona Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Alessandro Manzoni Hospital Lecco Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Azienda USL Toscana Sud Est Arezzo Italy
Azienda Sanitaria Locale Della Provincia Di Biella Ponderano Italy
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
IRST IRCCS Meldola Meldola Italy
Apmoaap Othzakewaxw Uwbusrcmnfspz Psoqp Parma Italy
Aivrrso Ofpbkmozmmw S Gxoolqrp Abnhocklvq Rome Italy
Iexma Irhygmco Fbdkucjlhfjnm Osflwovgioeh Ifnsxppe Nlesahzfb tlaowb Rdiyjh Eotbl Rome Italy
Aljqcdd Uzv Iwrgo Do Rtyxjx Efyjeo Reggio Emilia Italy

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

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
29.04.2021

Trial locations

Investigated drugs:

Durvalumab is a medication used in this clinical trial to help improve survival in patients with stage III non-small-cell lung cancer (NSCLC) who have relapsed after previous treatments. It is an immunotherapy drug that works by helping the immune system recognize and attack cancer cells more effectively.

Single Agent Chemotherapy refers to the use of one chemotherapy drug to treat cancer. In this trial, it is used in combination with durvalumab to see if it can further prolong survival in patients who have progressed during durvalumab maintenance therapy.

Investigated diseases:

Non-Small Cell Lung Cancer – 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 form of lung cancer, accounting for about 85% of all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms. Early detection is crucial for managing the disease effectively.

Trial ID:
2024-520081-65-00
Protocol code:
CONDOR
NCT ID:
NCT05568212
Trial Phase:
Therapeutic exploratory (Phase II)

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