Study on Thoracic Radiotherapy and Durvalumab for Elderly or Frail Stage III Non-Small Cell Lung Cancer Patients Unable to Undergo Chemotherapy

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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 stage III of the disease that cannot be removed by surgery. The treatment being tested is a combination of Durvalumab, also known by its code name MEDI4736, and a specialized form of radiation therapy. Durvalumab is a medication given through an infusion, which means it is delivered directly into the bloodstream through a vein. The study is designed for elderly and/or frail patients who are not suitable for chemotherapy.

The purpose of the study is to evaluate the safety and effectiveness of combining Durvalumab with two different types of radiation therapy. One type is the conventional method, and the other is an optimized method called hypofractionated radiotherapy, which involves giving larger doses of radiation over a shorter period. The study aims to see how well these treatments work together in improving the response rates in patients with this type of lung cancer.

Participants in the study will receive either the conventional or the hypofractionated radiation therapy along with Durvalumab. The study will monitor the safety of these treatments and how well they are tolerated by the patients. It will also look at how the cancer responds to the treatment over time. The study is expected to last for a period of up to 12 months, during which patients will have regular hospital visits for treatment and follow-up examinations.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a series of tests to ensure adequate bone marrow, renal, and hepatic function.

A pregnancy test is required for women of reproductive potential. Post-menopausal status is verified for applicable participants.

2 treatment planning

A treatment plan is developed, which includes thoracic radiotherapy and the administration of durvalumab. The radiotherapy may be either conventionally fractionated or hypofractionated, depending on the specific group assignment.

3 radiotherapy

Radiotherapy is administered to the chest area. The schedule and dosage depend on whether the treatment is conventionally fractionated or hypofractionated.

4 durvalumab administration

Durvalumab is given as an intravenous infusion. The concentration is 50 mg/mL, and it is prepared as a solution for infusion. The frequency and duration of administration are determined by the study protocol.

5 monitoring and follow-up

Regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes checking for any side effects, particularly treatment-related pneumonitis.

Follow-up visits are scheduled to evaluate the response to treatment and to monitor overall health status.

6 completion and evaluation

Upon completion of the treatment phase, a final evaluation is conducted to assess the overall response to the therapy.

The study aims to conclude by December 31, 2025, with ongoing assessments of treatment efficacy and safety.

Who Can Join the Study?

The patient must provide fully-informed written consent and any required local authorization before any study-related procedures are performed.
The patient must have at least one measurable site of disease as defined by specific medical criteria (RECIST 1.1).
The patient must have adequate bone marrow and kidney function, which includes:
- Hemoglobin level of at least 9.0 grams per deciliter (g/dL).
- Absolute neutrophil count of at least 1.0 x 10⁹ per liter (L).
- Platelet count of at least 75 x 10⁹ per liter (L).
- Creatinine clearance (a measure of kidney function) of at least 30 milliliters per minute (mL/min).
The patient must have adequate liver function, which includes:
- Serum bilirubin level no more than 1.5 times the normal upper limit.
- AST (a liver enzyme) and ALT (another liver enzyme) levels no more than 2.5 times the normal upper limit.
Female patients who can have children must have a negative pregnancy test within 7 days before starting the trial.
Female patients must show evidence of being post-menopausal or have a negative pregnancy test if they are pre-menopausal. Post-menopausal status is defined by specific criteria related to age and medical history.
The patient must be willing and able to follow the study protocol, including attending hospital visits for treatment and follow-up examinations.
The patient must be at least 18 years old.
The patient must have a confirmed diagnosis of unresectable stage III non-small-cell lung cancer (NSCLC).
The patient must not be suitable for sequential chemotherapy and radiotherapy, as determined by a team of medical specialists or the investigator.
The patient must meet at least one of the following criteria:
- Performance status of 2 on a specific scale (ECOG scale).
- Performance status of 1 on the ECOG scale and a Charlson Comorbidity Index (CCI) of at least 1.
- Age of 70 years or older.
The patient must have a life expectancy of at least 12 weeks.
The patient must have a lung function test result (FEV1) of at least 40% of the expected value.
The patient must have a lung diffusion capacity test result (DLCO or DLCO/VA) of at least 40% of the expected value.
The patient must have a lung volume test result (FVC or VC) of at least 70% of the expected value.

Who Cannot Join the Study?

Patients who have had surgery to remove the lung cancer cannot participate. This means the cancer must be unresectable, which means it cannot be removed by surgery.
Patients who are suitable for chemotherapy are not eligible. This study is for those who cannot have chemotherapy.
Patients with medical conditions that make it unsafe to receive the study treatments cannot participate.
Patients who are pregnant or breastfeeding are not eligible to join the study.
Patients who have another type of cancer that requires treatment are not eligible.
Patients who have had a severe allergic reaction to similar treatments in the past cannot participate.
Patients with certain heart conditions that could be worsened by the study treatments are not eligible.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Onkodok GmbH	Guetersloh	Germany
Staedtisches Klinikum Braunschweig gGmbH	Brunswick	Germany
Kliniken Maria Hilf GmbH Moenchengladbach	Moenchengladbach	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
RKH Klinken Ludwigsburg-Bietigheim gGmbH	Ludwigsburg	Germany
Pi.Tri Studien GmbH	Offenburg	Germany
Sana Klinikum Offenbach GmbH	Offenbach Am Main	Germany
SLK-Kliniken Heilbronn GmbH	Heilbronn	Germany
Vincentius-Diakonissen-Kliniken gAG	Karlsruhe	Germany
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH	Hemer	Germany
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Dgc Kxsbhgud Bhsggmzlazpa	Berlin	Germany
Ghpmmp Uobxubgujs Fkdqfcoug	Frankfurt	Germany
Gyuafqmdsnbpunuhgam fic Hqzpzvkuzjf uep Olwaobiba	Munster	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	29.05.2020

Trial locations

Investigated drugs:

Durvalumab

Durvalumab is a medication used in this trial to help the body’s immune system fight cancer. It is an immunotherapy drug that targets a specific protein on cancer cells, helping the immune system to recognize and attack these cells more effectively. In this trial, it is combined with radiotherapy to see if it improves the treatment outcomes for patients with stage III non-small cell lung cancer (NSCLC) who cannot undergo chemotherapy.

Thoracic Radiotherapy is a type of cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors in the chest area. In this trial, two different methods of delivering radiotherapy are being tested: conventionally fractionated radiotherapy and hypofractionated radiotherapy. The goal is to determine which method, when combined with durvalumab, is more effective and better tolerated by patients with stage III NSCLC who are not fit for chemotherapy.

Investigated diseases:

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. In stage III, the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body. The term “unresectable” indicates that the cancer cannot be removed completely through surgery. As the disease progresses, it may cause symptoms like persistent cough, chest pain, and difficulty breathing. Treatment often focuses on managing symptoms and slowing the progression of the disease.

Trial ID:

2024-513948-28-00

Protocol code:

TRADE-hypo

NCT ID:

NCT04351256

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Thoracic Radiotherapy and Durvalumab for Elderly or Frail Stage III Non-Small Cell Lung Cancer Patients Unable to Undergo Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?