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Study on the Safety and Effectiveness of Furmonertinib vs. Platinum-Based Chemotherapy for Patients with Advanced Non-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 Non-Small Cell Lung Cancer (NSCLC), a type of lung cancer that is common and can be challenging to treat, especially when it has spread to other parts of the body or is locally advanced. The study is comparing the effectiveness and safety of a medication called Furmonertinib with traditional platinum-based chemotherapy. Furmonertinib is a tablet taken orally, while platinum-based chemotherapy involves medications like Cisplatin, Carboplatin, and Pemetrexed, which are given through an infusion into a vein. These treatments are being tested as the first line of treatment for patients who have not received any prior systemic therapy for their advanced or metastatic NSCLC.

The purpose of the study is to determine how well Furmonertinib works compared to platinum-based chemotherapy in patients with a specific genetic mutation known as the EGFR exon 20 insertion mutation. This mutation affects the epidermal growth factor receptor, which plays a role in the growth and spread of cancer cells. The study will follow patients over time to see how long they live without their disease getting worse, which is known as progression-free survival (PFS). The study will also look at overall survival (OS), which is the time from the start of the study until death from any cause, and the objective response rate (ORR), which measures how many patients have a significant reduction in their cancer.

Participants in the study will be randomly assigned to receive either Furmonertinib or one of the platinum-based chemotherapy treatments. The study is open-label, meaning both the participants and the researchers know which treatment is being given. The trial will continue until 2028, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatments. This study aims to provide valuable insights into the best treatment options for patients with this specific type of lung cancer mutation.

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, the patient is randomly assigned to one of two treatment groups: one receiving furmonertinib and the other receiving platinum-based chemotherapy.
Step 2
Treatment with furmonertinib
If assigned to the furmonertinib group, the patient will take the medication orally in the form of a tablet. The dosage and frequency will be determined by the study protocol and communicated to the patient by the healthcare provider.
Step 3
Treatment with platinum-based chemotherapy
If assigned to the platinum-based chemotherapy group, the patient will receive a combination of medications including cisplatin, carboplatin, and pemetrexed. These medications are administered intravenously, meaning they are given through a vein.
The specific dosage and schedule for each medication will be provided by the healthcare team. The treatment cycle typically involves receiving the medications on specific days followed by a rest period.
Step 4
Monitoring and assessments
Throughout the study, the patient's health and response to treatment are closely monitored. This includes regular medical assessments, imaging tests, and laboratory tests to evaluate the effectiveness of the treatment and to check for any side effects.
Step 5
Completion of treatment
The treatment continues until the study's endpoint is reached, which may include disease progression or completion of the treatment period as defined by the study protocol.
Step 6
Follow-up
After completing the treatment phase, the patient will have follow-up visits to monitor their health status and any long-term effects of the treatment.

Who can join the trial?

5 criteria

The patient must have a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that is either locally advanced or has spread to other parts of the body. This cancer cannot be treated with surgery or radiation to cure it.
The patient must have test results showing a specific change in the cancer called an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation. This can be found in the tumor tissue or blood.
The patient must not have received any previous treatments for their advanced or spreading lung cancer, including treatments that target the EGFR mutation.
If the patient has had treatments like chemotherapy, immunotherapy, or a combination of chemotherapy and radiation for cancer that has not spread, they must have been free from treatment for at least 12 months. This does not include treatments targeting EGFR.
The patient can participate if they have had brain metastases (cancer spread to the brain) that have been treated or if they have new brain metastases that are not causing symptoms.

Who cannot join the trial?

8 criteria

Patients who have received previous treatment for their lung cancer.
Patients with a different type of lung cancer other than non-squamous non-small cell lung cancer.
Patients without the specific genetic change called EGFR exon 20 insertion mutations. This is a change in the DNA of the cancer cells that affects how they grow.
Patients who are not within the specified age range for the study.
Patients who are unable to follow the study procedures or attend the required visits.
Patients with other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Hospices Civils De Lyon
Responsive
Lyon, France
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

Trial locations

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Investigated drugs

Furmonertinib
is a medication being studied for its effectiveness in treating patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC) that has certain genetic changes called EGFR exon 20 insertion mutations. This medication is being tested to see if it can help stop the cancer from growing or spreading in patients who have not received any previous treatment for their advanced or metastatic cancer.
Platinum-Based Chemotherapy
is a standard treatment for various types of cancer, including lung cancer. It involves using drugs that contain the metal platinum to kill cancer cells or stop them from growing. In this study, platinum-based chemotherapy is being used as a comparison to see how well furmonertinib works in treating patients with the specific type of lung cancer mentioned above.

What is already known about the treatment

Furmonertinib – Furmonertinib is administered orally and is currently being studied in clinical trials as a potential treatment for non-small cell lung cancer (NSCLC) with specific genetic mutations. It is in the investigational stage, with ongoing research to determine its effectiveness compared to traditional platinum-based chemotherapy. The main therapeutic indication for furmonertinib is for patients with locally advanced or metastatic NSCLC who have not received prior treatment and have epidermal growth factor receptor (EGFR) exon 20 insertion mutations. At the molecular level, furmonertinib works by inhibiting the activity of the EGFR, which is involved in the growth and spread of cancer cells. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Non-Small Cell Lung Cancer – 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. The disease typically starts in the cells lining the lungs and can spread to other parts of the body. It often grows and spreads more slowly than small cell lung cancer. 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.