Study of accelerated chemoradiotherapy followed by durvalumab treatment in patients with locally advanced non-small-cell lung cancer (NSCLC) using PET imaging guidance

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What is this study about?

This study focuses on patients with locally advanced non-small-cell lung cancer (Stage III) that cannot be surgically removed and shows specific protein expression (PD-L1) on cancer cells. The treatment combines three approaches: radiation therapy, chemotherapy containing platinum drugs, and an immunotherapy medication called durvalumab (also known as IMFINZI).

The purpose is to evaluate if using a special imaging technique called FDG-PET to guide a faster-paced radiation treatment combined with chemotherapy and immunotherapy works as well as the standard treatment approach. During the study, patients will receive radiation therapy together with chemotherapy, followed by immunotherapy treatment with durvalumab, which will be given through an infusion into a vein.

The treatment period with durvalumab may continue for up to 12 months. Throughout the study, doctors will monitor patients’ response to treatment and check for any side effects. The study will also look at how long patients remain free from cancer progression and their overall survival, as well as measure their quality of life during and after treatment.

1 Initial evaluation

Your medical condition will be confirmed as locally advanced, unresectable non-small-cell lung cancer (Stage III) with a specific protein marker (PD-L1) level of 1% or higher

A special imaging scan called FDG-PET CT will be performed to assess your tumor

2 Treatment phase 1: Combined therapy

You will receive chemotherapy containing platinum-based drugs

At the same time, you will undergo radiotherapy treatments targeting the tumor area

The exact number of radiotherapy sessions will be determined by your treatment plan

3 Treatment phase 2: Immunotherapy

Within 42 days after completing the combined therapy, you will start receiving durvalumab (IMFINZI)

Durvalumab is given as an infusion into your vein

You will receive at least 3 doses of durvalumab, unless stopped earlier due to side effects outside the chest area

4 Monitoring and follow-up

Regular checks will be performed to monitor your response to treatment

Your doctor will assess any side effects using a standardized rating system

You will complete quality of life questionnaires about your symptoms and general well-being

The study will continue monitoring your progress to measure how long the treatment remains effective

Who Can Join the Study?

Must provide written informed consent to participate in the study
Must have adequate bone marrow and organ function, including:
– Hemoglobin level at least 9.0 g/dL
– White blood cell count above 1.5 × 109/L
– Platelet count above 100 × 109/L
– Normal liver function tests
– Kidney function showing creatinine clearance above 40 mL/min
Must weigh more than 30 kilograms
Must be 18 years or older
Must have confirmed non-small-cell lung cancer that is locally advanced and cannot be surgically removed (Stage III)
Must have a tumor that tests positive for PD-L1 (a protein) at 1% or higher
Must be able to undergo combined chemotherapy and radiation therapy, followed by immunotherapy
Must have an ECOG performance status of 0 or 1 (meaning able to carry out light daily activities)
Must have had a PET-CT scan within 21 days before starting treatment
Must have adequate lung function test results showing:
– Forced breathing volume of at least 1.0 L or above 40% of expected
– Lung capacity for carbon monoxide above 30% of expected
For women who can become pregnant and men with partners who can become pregnant: Must agree to use effective birth control during treatment and for at least 90 days after the last dose of durvalumab or 6 months after the last chemotherapy dose
Must be willing and able to attend all scheduled visits and complete required tests

Who Cannot Join the Study?

History of small cell lung cancer (a different, more aggressive type of lung cancer)
Previous radiation therapy to the chest area
PD-L1 expression less than 1% (a specific protein marker on cancer cells)
Presence of cancer that has spread to other parts of the body (metastatic disease)
Serious heart conditions or uncontrolled high blood pressure
Active or untreated brain metastases (cancer spread to the brain)
Active autoimmune disease requiring systemic treatment
Current use of medications that suppress the immune system
Uncontrolled infections, including HIV, hepatitis B, or hepatitis C
Participation in another clinical trial within the past 30 days
Pregnancy or breastfeeding
Known allergy or sensitivity to study medications
Any condition that would make it unsafe to receive chemotherapy and radiation
Unable to undergo FDG-PET scanning (a special imaging test that shows cancer activity)
Mental conditions that could interfere with study compliance

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Technische Universitaet Dresden	Dresden	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany

Other Sites

Site Name	City	Country
Pius-Hospital Oldenburg	Oldenburg In Holstein	Germany
Kliniken Maria Hilf GmbH Moenchengladbach	Moenchengladbach	Germany
Onkologie Rheinsieg Praxisnetzwerk	Troisdorf	Germany
Saarland University Hospital	Homburg	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Vinzenz Von Paul Kliniken gGmbH	Stuttgart	Germany
Kgtqnblp dbm Uavvlwqhnslm Msnugbyk Ayc	Munich	Germany
Uugxumatntcbwuhxjqfnv Embvw Akf	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.08.2024

Trial locations

Investigated drugs:

Durvalumab

Durvalumab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that cancer cells use to hide from your immune system, allowing your body’s natural defenses to better recognize and attack the tumor.

Chemoradiotherapy is a combined treatment approach that uses both chemotherapy and radiation therapy together. The chemotherapy drugs make cancer cells more sensitive to radiation treatment, while radiation therapy uses high-energy rays to destroy cancer cells.

FDG-PET scanning is an imaging technique that uses a special type of sugar (glucose) containing a radioactive tracer. This helps doctors see where cancer cells are in the body, as cancer cells typically use more glucose than normal cells. This scanning method is used to guide the treatment planning.

Investigated diseases:

Non-small cell lung cancer stage III

Non-small-cell lung cancer (NSCLC) – A type of lung cancer that develops in the outer parts of the lungs, accounting for most lung cancer cases. It begins when healthy cells in the lung change and grow out of control, forming a mass called a tumor. The disease typically develops slowly and can spread from its original location to nearby tissues and other parts of the body. Stage III NSCLC means the cancer has spread to lymph nodes near the center of the chest but has not spread to distant parts of the body. The term “locally advanced” indicates that the cancer has grown into nearby structures in the chest, making it harder to treat with surgery alone.

Trial ID:

2023-510506-41-00

Protocol code:

ESR-21-21536

NCT ID:

NCT06102057

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of accelerated chemoradiotherapy followed by durvalumab treatment in patients with locally advanced non-small-cell lung cancer (NSCLC) using PET imaging guidance

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?