Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A multicentre phase II, open-label, non-randomized study evaluating Platinum-Pemetrexed-Atezolizumab ( Bevacizumab) for patients with stage IIIB/IV non-squamous non-small cell lung cancer with EGFR mutations, ALK rearrangement or ROS1 fusion progressing after Targeted therapies

This study is for people with a common type of lung cancer called non-small cell lung cancer (NSCLC) that has spread or is advanced (Stage IIIB/IV). Participants will have specific genetic changes (EGFR, ALK, or ROS1) and their cancer will have started growing again after earlier targeted treatments. The study uses a mix of chemotherapy drugs (like Cisplatin or Carboplatin, and Pemetrexed) alongside newer drugs called Atezolizumab and Bevacizumab. Researchers want to find out how many patients' tumours shrink or disappear after treatment. They'll also monitor how long people live, how long they stay well without their cancer getting worse, and how the treatment affects their symptoms and side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Francois Baclesse

Enrolment target

150

Start

05 Nov 2024

Lung Cancer NSCLC

What is this study about?

This clinical trial is designed for people who have a specific type of lung cancer called non-small cell lung cancer (NSCLC). This is the most common kind of lung cancer. The study is for advanced stages of the disease (Stage IIIB or IV), meaning it has spread beyond the lung or to other parts of the body. Importantly, this study is for patients whose cancer has certain genetic changes (called EGFR mutations, ALK rearrangements, or ROS1 fusions) and whose disease has started to grow again even after they've had targeted treatments for these specific genetic changes.

The main goal of this study is to see how well a combination of existing medicines works for these patients. The treatment involves a mix of standard chemotherapy drugs (like Cisplatin or Carboplatin, and Pemetrexed) given together with two newer drugs, Atezolizumab (also known as Tecentriq) and Bevacizumab (also known as Avastin). Atezolizumab is a type of immunotherapy that helps your own immune system fight cancer, while Bevacizumab works by stopping new blood vessels from growing to feed the tumour.

The researchers will closely watch how patients respond to this combination. Their main focus is to see how many people experience their tumours shrinking or disappearing after treatment – this is called the 'objective response rate'. They will also be looking at how long patients stay well without their cancer getting worse, how long they live overall, and how the treatment affects symptoms like cough or breathlessness. Checking for any side effects from the treatment is also a very important part of the study.

Key takeaways

Targets advanced non-small cell lung cancer (NSCLC) that has specific genetic changes and progressed after prior treatments.
Combines standard chemotherapy with newer immunotherapy (Atezolizumab) and anti-blood vessel growth drug (Bevacizumab).
Aims to assess tumour shrinkage and control of cancer growth.
Will closely monitor patient well-being, symptoms, and potential side effects.
Participation involves regular hospital visits for treatment and assessments.

Who may be eligible?

To join this study, you must be at least 18 years old. It's for both men and women. You must have a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced, meaning it has spread or is considered Stage IIIB or IV.

Crucially, your cancer must have specific genetic changes, which doctors call EGFR mutations, ALK rearrangements, or ROS1 fusions. You must also have received targeted treatments for these genetic changes in the past, and your cancer must have unfortunately started to grow again after those treatments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced non-small cell lung cancer (NSCLC)?
Has your doctor told you your cancer has EGFR, ALK, or ROS1 genetic changes?
Has your cancer started growing again after previous targeted treatments for these genetic changes?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital for your treatment and check-ups. You would receive a combination of medicines as infusions, which means they are given directly into your bloodstream, similar to a drip. There will be initial "induction" cycles of treatment, followed by ongoing "maintenance" cycles if the treatment is working well for you.

During the study, you would have scans regularly to check how your cancer is responding. These scans will be looked at by different doctors to make sure results are consistent. You would also have blood tests and regular assessments to monitor your general health, any side effects you might experience, and how your symptoms are changing. The exact number of visits and the full length of your participation would depend on how your cancer responds to the treatment.

Potential risks and benefits

Participating in this study might offer a potential benefit if this new treatment combination proves to be more effective than other options for your specific type of cancer. It could lead to your cancer shrinking or slowing its growth, and potentially improve your symptoms. However, like all medical treatments, there are potential risks and side effects. These could include common side effects from chemotherapy, immunotherapy, and other drugs, which your doctor will explain in detail. You will be closely monitored for any reactions, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What type of cancer is this study for?

This study is for advanced non-small cell lung cancer (NSCLC) that has specific genetic changes and has grown after previous targeted treatments.

What kind of treatment will I receive?

You will receive a combination of chemotherapy drugs (like Pemetrexed, Cisplatin or Carboplatin) along with two other drugs, Atezolizumab and Bevacizumab, given as infusions.

Will this treatment cure my cancer?

This study aims to see if the new combination of drugs can shrink your cancer or stop it from growing for longer. It's a therapeutic study, meaning it explores new ways to treat the disease rather than looking for a cure.

What are the main things the doctors are looking for?

The main goal is to see how many patients respond well, meaning their tumours shrink. They will also track how long people live, how long they stay well, and any side effects.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, and this will not affect your medical care.