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Study on the Effectiveness and Safety of Durvalumab and Olaparib for Patients with Stage IV Non-Small Cell Lung Cancer After Initial Chemotherapy

Registered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a type of lung cancer known as Stage IV Non-Small Cell Lung Cancer (NSCLC). This is a form of cancer that has spread beyond the lungs and does not have certain genetic changes called EGFR mutations and ALK fusions. The study is investigating the effectiveness and safety of a combination treatment using two medications: durvalumab and olaparib. Durvalumab, also known by its code name MEDI4736, is a medication given through an intravenous infusion, which means it is administered directly into the bloodstream. Olaparib is taken orally in the form of film-coated tablets.

The purpose of the study is to compare the combination of durvalumab and olaparib with durvalumab alone in patients whose cancer has not worsened after initial treatment with durvalumab and chemotherapy. Participants will receive either the combination therapy or durvalumab alone as maintenance therapy, which is a treatment given to help keep cancer from coming back after it has responded to initial treatment. The study will monitor the patients over time to see how well the treatments work and to check for any side effects.

Throughout the study, patients will be regularly assessed to track the progression of their cancer and their overall health. This includes monitoring for any changes in their condition and evaluating their response to the treatment. The study aims to provide valuable information on whether the combination of durvalumab and olaparib can offer better outcomes for patients with this type of lung cancer compared to using durvalumab alone.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including having Stage IV non-small cell lung cancer without certain genetic mutations.
The ability to swallow oral medications is required, and adequate organ function must be demonstrated.
Step 2
Initial treatment phase
The initial treatment involves four cycles of platinum-based chemotherapy combined with durvalumab.
This phase aims to stabilize the disease before moving to the maintenance phase.
Step 3
Randomization and maintenance treatment
After the initial treatment, randomization occurs to assign either durvalumab alone or a combination of durvalumab and olaparib.
Durvalumab is administered as an intravenous infusion, while olaparib is taken orally in the form of 150 mg film-coated tablets.
Step 4
Treatment administration
Durvalumab is given as an infusion at a concentration of 50 mg/mL.
Olaparib tablets are taken orally, with the dosage and frequency determined by the study protocol.
Step 5
Monitoring and assessments
Regular monitoring includes physical examinations, laboratory tests, and assessments of disease progression.
Progression-free survival and overall survival are key measures, along with response rates and duration of response.
Step 6
Completion of the study
The study is estimated to conclude by February 28, 2026.
Final assessments will determine the effectiveness and safety of the treatments.

Who can join the trial?

10 criteria

The patient must have **Stage IV Non-Small Cell Lung Cancer (NSCLC)**, which means the cancer has spread to other parts of the body and cannot be treated with surgery or radiation to cure it.
The patient's tumors must not have specific changes called **EGFR mutations** or **ALK fusions**.
The patient should have a **performance status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The patient must not have had any chemotherapy or other treatments that affect the whole body for Stage IV NSCLC before.
The patient should have **adequate organ and marrow function**, meaning their organs and bone marrow are working well, and they haven't needed a blood transfusion in the last 28 days.
The patient must have at least one tumor that hasn't been treated with radiation and can be measured accurately.
The patient should have evidence of **CR (Complete Response)**, **PR (Partial Response)**, or **SD (Stable Disease)** after 4 cycles of platinum-based chemotherapy, as assessed by the doctor.
The patient must have a **creatinine clearance (CrCl)** of at least 51 mL/min, which is a measure of kidney function, calculated by the doctor using a specific formula or by collecting urine over 24 hours.
The patient must be able to swallow whole oral medications and should not have any gastrointestinal (GI) illnesses that prevent this.
The study is open to both male and female patients.

Who cannot join the trial?

3 criteria

Patients with **Stage IV Non-Small Cell Lung Cancer** whose tumors have **EGFR mutations** or **ALK fusions** cannot participate. **EGFR mutations** and **ALK fusions** are specific changes in the cancer cells that affect how the cancer grows.
Patients who are not within the specified age range 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.

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Investigated drugs

Durvalumab
is a medication used in this study as a monotherapy and in combination with another drug. It is an immunotherapy that helps the body's immune system to detect and fight cancer cells. In this trial, it is used as a maintenance therapy for patients with stage IV non-small cell lung cancer who have already received standard chemotherapy.
Olaparib
is a medication used in combination with durvalumab in this study. It is a type of targeted therapy known as a PARP inhibitor, which works by preventing cancer cells from repairing their DNA, leading to their death. This combination aims to enhance the effectiveness of the treatment in maintaining the patient's condition after initial chemotherapy.

What is already known about the treatment

Durvalumab
This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Stage IV Non-Small Cell Lung Cancer without specific genetic mutations. It is primarily used as a maintenance therapy after initial chemotherapy. Durvalumab works by blocking a protein that prevents the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor. It is classified as an immune checkpoint inhibitor.
Olaparib
This medication is taken orally and is being evaluated in combination with durvalumab for its potential benefits in treating advanced lung cancer. It is used to maintain the effects of initial chemotherapy. Olaparib functions by inhibiting an enzyme involved in DNA repair, leading to cancer cell death, especially in cells with certain genetic defects. It belongs to a class of drugs known as PARP inhibitors.

Investigated diseases

Stage IV Non-Small Cell Lung Cancer – This is an advanced form of lung cancer where the disease has spread beyond the lungs to other parts of the body. It is characterized by the absence of specific genetic mutations known as EGFR mutations and ALK fusions, which are sometimes present in other types of lung cancer. The progression of this disease involves the growth and spread of cancerous cells, leading to symptoms such as persistent cough, chest pain, and difficulty breathing. As the cancer advances, it may affect other organs, causing additional symptoms depending on the areas involved. The disease is typically diagnosed at a late stage, making it more challenging to manage.