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Study on Maintenance Therapy with Durvalumab and Olaparib for Patients with Extensive Disease Small-Cell Lung Cancer

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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 small-cell lung cancer (SCLC), which is a fast-growing form of lung cancer. The study is specifically looking at patients with a subtype called extensive disease (ED) small-cell lung cancer, which means the cancer has spread widely in the body. The trial will use two medications: olaparib and durvalumab. Olaparib is taken as a tablet, while durvalumab, also known by its code name MEDI4736, is given as an infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how effective these medications are when used as maintenance therapy, which means they are given after the initial standard treatment to help keep the cancer from coming back. The standard first-line treatment usually includes a combination of chemotherapy drugs like carboplatin or cisplatin, etoposide, and durvalumab. After completing this initial treatment, patients will receive olaparib and durvalumab to see if these medications can help maintain the benefits of the first treatment.

During the study, participants will receive the medications for a period of time, and their health will be monitored regularly. This includes checking for any side effects and assessing how well the cancer is being controlled. The study aims to understand if this combination of treatments can improve outcomes for patients with this type of lung cancer. Some participants may receive a placebo instead of the active medications to compare the effects. The trial is expected to continue until 2027, with recruitment starting in 2024.

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
Initiation of maintenance therapy
The maintenance therapy begins after completing the initial treatment with carboplatin or cisplatin, etoposide, and durvalumab. This initial treatment consists of four cycles, each lasting 21 days.
The maintenance phase involves the administration of two medications: olaparib and durvalumab.
Step 2
Medication administration
Olaparib is provided in the form of film-coated tablets. The dosage is either 150 mg or 100 mg, taken orally.
Durvalumab is administered as a solution for infusion, with a concentration of 50 mg/mL.
Step 3
Treatment schedule
The treatment schedule for olaparib involves taking the tablets twice daily.
The infusion of durvalumab is scheduled every four weeks.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the response to the treatment and to manage any side effects.
Follow-up visits are scheduled to evaluate the progression-free survival and other health parameters.
Step 5
Duration of the trial
The estimated end date for the trial is February 28, 2027.
The trial aims to evaluate the effectiveness of the maintenance therapy in patients with advanced or metastatic small-cell lung cancer.

Who can join the trial?

19 criteria

Must be at least 18 years old.
Must have advanced or metastatic small-cell lung cancer that cannot be treated with surgery or radiation.
Must provide written consent to participate in the study.
Must be receiving or planning to receive specific cancer treatments: carboplatin or cisplatin, etoposide, and durvalumab.
Must have recent chest and abdominal scans (CT or MRI) available.
Must have at least one measurable area of cancer as defined by specific medical criteria.
Must be willing and able to follow the study's procedures and attend scheduled visits.
Must have a positive test for a specific genetic condition called homologous recombination deficiency (HRD).
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures daily living abilities.
Must weigh more than 30 kg (about 66 pounds).
Must have a life expectancy of at least 12 weeks.
Must not have worsening cancer while on initial treatment.
Must have recent tumor assessment scans that meet specific technical requirements.
Must have completed four cycles of specific chemoimmunotherapy treatment.
Must have recovered from any side effects if chemotherapy doses were reduced.
Must have adequate organ and bone marrow function, as shown by specific blood test results.
Women of childbearing potential must use effective birth control and have a negative pregnancy test.
Men must use condoms and ensure their partners use effective birth control.
Must not donate eggs or sperm during the study and for a specified period after the last dose of the study drug.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than the one being studied.
Patients who have had another cancer treatment recently that might interfere with the study.
Patients with serious health conditions that could make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures for any reason.
Patients who have allergies to the study medications.
Patients who have participated in another clinical trial recently.
Patients with certain infections that could affect the study results.
Patients who have a history of certain heart problems.
Patients who are not able to give informed consent, which means they cannot understand and agree to the study details.

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Verified sites

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Thoraxklinik Heidelberg gGmbH
Responsive
Heidelberg, Germany
University Hospital Cologne
Verified
Cologne, Germany

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Investigated drugs

Durvalumab
is a medication used to help the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the body to better target and destroy them. In this trial, it is used as part of a maintenance therapy to help keep small-cell lung cancer from returning after initial treatment.
Olaparib
is a medication that targets cancer cells with specific genetic defects, particularly those involved in DNA repair. It helps to prevent cancer cells from repairing themselves, leading to their death. In this trial, olaparib is used alongside durvalumab as a maintenance therapy to help control small-cell lung cancer in patients with certain genetic characteristics.

What is already known about the treatment

Durvalumab
This medication is administered as an intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic small-cell lung cancer. It is primarily used as an immunotherapy to help the body's immune system attack cancer cells. Durvalumab works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. It is classified as a monoclonal antibody.
Olaparib
This medication is taken orally in tablet form and is under investigation for its potential benefits in treating advanced or metastatic small-cell lung cancer. It is mainly used as a targeted therapy for cancers with specific genetic mutations. Olaparib functions by inhibiting an enzyme called PARP, which helps repair DNA damage in cells, leading to the death of cancer cells. It is classified as a PARP inhibitor.

Investigated diseases

Small-cell lung cancer – This is a type of lung cancer characterized by small cells that multiply quickly and form large tumors. It is often associated with smoking and tends to spread rapidly to other parts of the body, including the lymph nodes and distant organs. The disease is typically classified into two stages: limited stage, where cancer is confined to one lung and nearby lymph nodes, and extensive stage, where it has spread more widely. Symptoms may include coughing, chest pain, shortness of breath, and weight loss. Due to its aggressive nature, small-cell lung cancer often requires prompt medical attention.