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Study of radiotherapy with durvalumab and ceralasertib in patients with stage III non-small cell lung cancer who have thoracic relapse after PACIFIC treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Stage III Non-Small Cell Lung Cancer who have experienced a relapse in the chest area after previous treatment. The study will evaluate a combination treatment that includes radiotherapy followed by two medications: durvalumab and ceralasertib (also known as AZD6738). Durvalumab is given through an infusion into a vein, while ceralasertib is taken as tablets by mouth.

The main purpose of this research is to test how safe and effective this combination treatment is for patients whose cancer has returned after previous therapy. The study will monitor how well patients tolerate the treatment and how it affects the progression of their disease. Some patients in the study may also have up to three areas where the cancer has spread to other parts of the body.

During the study, participants will receive radiotherapy treatment first, followed by both medications. Durvalumab will be given as an infusion at a dose of up to 1500 mg, while ceralasertib will be taken as tablets with a maximum daily dose of 480 mg. The treatment period may continue for up to 36 months, during which patients will have regular check-ups to monitor their health and how well the treatment is working.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your eligibility for the study will be confirmed through medical examinations, including CT scan, CT-PET scan, and brain MRI
The medical team will verify that more than 12 months have passed since your previous thoracic radiation therapy
A review of your medical history and current health status will be conducted
Step 2
Radiation therapy phase
You will receive radiation therapy to treat the thoracic area affected by cancer
The exact duration and schedule of radiation therapy will be determined by your medical team
Step 3
Combined medication treatment
After radiation therapy, you will receive two medications:
Durvalumab will be administered through an intravenous infusion
Ceralasertib will be taken as oral tablets
Step 4
Monitoring period
Regular medical evaluations will be conducted for 6 months from the start of treatment
Your response to treatment will be assessed through imaging scans
Any side effects will be monitored and documented
The medical team will track your progress using RECIST criteria (a standardized way to measure if tumors are responding to treatment)
Step 5
Extended follow-up
Your health status will continue to be monitored for up to 12 months
Regular assessments will track your long-term response to treatment
Additional scans and medical examinations will be performed as needed

Who can join the trial?

15 criteria

Must be at least 18 years old
Must provide signed and dated informed consent
Must have a life expectancy of at least 6 months
Must weigh more than 30 kilograms
Must have received durvalumab treatment for at least 3 months
Must have confirmed advanced lung cancer (NSCLC) at relapse through tissue or cell examination
Must have measurable disease that can be evaluated using specific measurement criteria (RECIST v1.1)
Must have documented PD-L1 status (a type of protein marker) at first diagnosis or at relapse
Must have disease progression in the chest area, with no more than 3 metastatic lesions (areas where cancer has spread) that can be treated with radiation
Must have waited at least 12 months since completing first chest radiation therapy
Must undergo full body CT scan and CT-PET scan with contrast dye before treatment
Must have brain MRI scan before treatment
For women: Must be post-menopausal or have negative pregnancy test if pre-menopausal
Must be willing and able to follow study procedures and attend all scheduled visits
Must have good physical function ability (ECOG Performance Status of 0-2, meaning able to perform most daily activities)

Who cannot join the trial?

9 criteria

Patients with EGFR mutations (changes in a gene that helps control cell growth)
Patients with HER-2 mutations (changes in a gene related to breast cancer)
Patients with MET exon14 skipping mutations (specific genetic changes affecting cell growth)
Patients with ALK rearrangements (abnormal changes in a gene that can affect cancer growth)
Patients with ROS1 rearrangements (specific genetic changes that can affect cancer development)
Patients with RET rearrangements (changes in genes that can lead to cancer growth)
Patients with NTRK rearrangements (abnormal changes in genes that affect cell growth)
Patients who had a relapse within less than 12 months after completing their previous treatment
Patients with more than 3 metastatic lesions (spots where cancer has spread to other parts of the body)

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Parma
Parma, Italy

Trial locations

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Investigated drugs

Durvalumab (also known as MEDI4736) is a type of immunotherapy medication that helps the body's immune system fight cancer cells. It works by blocking a protein that cancer cells use to hide from the immune system, allowing the body's natural defenses to better recognize and attack the tumor. Ceralasertib (also known as AZD6738) is a targeted therapy medication that works by blocking specific proteins involved in DNA repair in cancer cells. By interfering with this repair process, it can make cancer cells more vulnerable to other treatments, particularly radiation therapy. Radiation therapy is a treatment that uses high-energy beams to target and destroy cancer cells. In this trial, it is used before the medication treatment begins to help shrink tumors and control cancer growth in patients with non-small cell lung cancer (NSCLC).

What is already known about the treatment

Durvalumab
A monoclonal antibody administered through intravenous infusion that works by blocking the PD-L1 protein, enhancing the immune system's ability to fight cancer cells. This medication is currently approved for treating non-small cell lung cancer (NSCLC) and is commonly used in the PACIFIC treatment regimen. It belongs to the class of immune checkpoint inhibitors and works by preventing cancer cells from evading immune system detection.
Ceralasertib
An oral medication that functions as an ATR kinase inhibitor, designed to prevent cancer cells from repairing their DNA damage, making them more vulnerable to treatment. This investigational drug is being studied in combination with durvalumab for treating advanced non-small cell lung cancer, particularly in cases with disease progression after initial treatment. It belongs to the class of targeted therapy drugs and represents a new approach in cancer treatment by interfering with specific molecular pathways involved in cancer cell survival.

Investigated diseases

Non-small Cell Lung Cancer (NSCLC), Stage III - A type of lung cancer that begins in the larger lung cells and develops more slowly than small cell lung cancer. In stage III, the cancer has spread to lymph nodes around the lungs or to nearby structures but has not spread to distant parts of the body. The disease typically starts in the cells lining the air passages of the lungs and can cause symptoms such as persistent cough, chest pain, and difficulty breathing. Stage III NSCLC can progress locally within the chest cavity, affecting nearby tissues and lymph nodes. The condition may involve one or both lungs and can develop loco-regional relapses even after initial treatment.