Study on Ceralasertib and Trastuzumab Deruxtecan for Patients with Non-Small Cell Lung Cancer After Anti-PD-1/PD-L1 Therapy

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What is this study about?

This clinical trial is focused on studying treatments for non-small cell lung cancer (NSCLC), a type of lung cancer. The study involves several medications, including AZD6738 (also known as ceralasertib), DS-8201a (also known as trastuzumab deruxtecan), mycophenolate mofetil, infliximab, and IMFINZI (also known as durvalumab). These medications are being tested to see how effective they are in treating patients whose cancer has progressed after receiving previous treatments that included anti-PD-1 or PD-L1 therapies.

The purpose of the study is to evaluate the effectiveness of each treatment by looking at how well the cancer responds. Participants in the study will receive one or more of these medications, which may be given as tablets, infusions, or capsules, depending on the specific treatment. Some participants may receive a placebo. The study will monitor the participants over a period of time to observe the effects of the treatments on their cancer.

Throughout the study, participants will undergo regular assessments to track the progress of their cancer and any changes in their health. The study aims to gather information on how these treatments can help manage NSCLC, especially in cases where the cancer has not responded to previous therapies. This research is important for developing new treatment options for patients with this type of lung cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, type of lung cancer, and previous treatments.

A new tumor biopsy may be required unless a recent sample is available.

2 treatment initiation

The study involves multiple medications, each administered differently. The medications include ceralasertib (AZD6738) taken orally as a film-coated tablet, trastuzumab deruxtecan (DS-8201a) given intravenously as a solution for infusion, mycophenolate mofetil taken orally, infliximab administered intravenously, and durvalumab (IMFINZI) given intravenously as a concentrate for infusion.

The specific medication and dosage depend on individual treatment plans.

3 treatment monitoring

Regular monitoring of treatment response is conducted using imaging and other assessments to measure tumor size and progression.

The primary goal is to evaluate the objective response rate, which indicates how well the cancer responds to the treatment.

4 evaluation of treatment outcomes

Secondary outcomes include overall survival, disease control rate, best percentage change in tumor size, duration of response, and progression-free survival.

These outcomes help determine the effectiveness of the treatment over time.

5 completion of the study

The study is estimated to conclude by August 13, 2024.

Upon completion, final assessments are conducted to evaluate the overall impact of the treatment.

Who Can Join the Study?

Must be at least 18 years old when signing the consent form.
Must have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that is either spreading or has come back after treatment.
Eligible for further treatment after having received specific therapies, including an anti PD-1/PD-L1 therapy and a platinum-doublet regimen. These are types of cancer treatments. The cancer must have worsened after these treatments.
Must be able to provide a new sample of the tumor for testing. In some cases, a recent sample taken within the last 24 months may be acceptable.
Must have a performance status of 0 to 1, which means being fully active or having some symptoms but still able to carry out light work. Must also have a life expectancy of at least 12 weeks.
Must have at least one tumor that can be measured accurately. If a tumor was treated with radiation before, it can still be measured if it has grown since then.
For women who can have children, there must be proof of being post-menopausal or a negative pregnancy test.

Who Cannot Join the Study?

Patients who have a different type of cancer other than non-small cell lung cancer (NSCLC).
Individuals who are not within the specified age range for the study.
People who are not able to give informed consent or understand the study requirements.
Patients who are pregnant or breastfeeding.
Individuals with other serious health conditions that might interfere with the study.
Patients who have participated in another clinical trial recently.
Individuals who are allergic to the study medication or its ingredients.
Patients who are currently receiving treatment that might conflict with the study medication.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital Universitario Virgen Macarena	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Stadt Wien Wiener Gesundheitsverbund	Vienna	Austria
Ilxkptsc Baeltwxb	Bordeaux	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	18.12.2017
France	Not recruiting	18.12.2017
Germany	Not recruiting	18.12.2017
Spain	Not recruiting	18.12.2017

Trial locations

Investigated drugs:

Anti-PD-1/PD-L1 Therapy is a type of cancer treatment that helps the immune system fight cancer. It works by blocking the PD-1 or PD-L1 proteins, which can prevent the immune system from attacking cancer cells. This therapy is used in patients with non-small cell lung cancer who have already been treated with similar therapies but need further treatment due to disease progression.

Biomarker-Directed Therapy involves using specific biological markers found in the patient’s cancer cells to guide treatment decisions. This approach aims to tailor the treatment to the individual characteristics of the cancer, potentially improving the effectiveness of the therapy.

Multi-Drug Therapy refers to the use of more than one medication to treat cancer. This approach can help target different pathways that cancer cells use to grow and survive, potentially increasing the chances of treatment success.

Investigated diseases:

Non-small cell lung cancer metastatic

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 the most common type of lung cancer, accounting for about 85% of all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages 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 may lead to more severe respiratory issues and other systemic symptoms.

Trial ID:

2023-509004-15-00

Protocol code:

D6185C00001

NCT ID:

NCT03334617

Trial Phase:

Therapeutic use (Phase IV)

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Study on Ceralasertib and Trastuzumab Deruxtecan for Patients with Non-Small Cell Lung Cancer After Anti-PD-1/PD-L1 Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?