Active not recruitingPHASE2INTERVENTIONAL

Combination of Paclitaxel-bevacizumab ± Atezolizumab in Patients With Advanced NSCLC Progressing After Immunotherapy & Chemotherapy

This study is for people with advanced non-small cell lung cancer (NSCLC) that has continued to grow after they've had both immunotherapy and chemotherapy. Doctors are trying to find better ways to treat this type of cancer. In this study, some people will receive two anti-cancer medicines called paclitaxel and bevacizumab. Others will get these two medicines plus a third one called atezolizumab. Researchers want to see if adding atezolizumab helps more people live longer without their cancer progressing. The study is open to both men and women aged 18 and over who meet specific health requirements. The main goal is to find out if at least 66% of patients receiving the three-drug combination show no cancer growth after six months. This will help doctors understand if this new combination is a promising treatment.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Enrolment target

156

Start

26 Apr 2023

Estimated completion

01 Jun 2026

Non Small Cell Lung Cancer

What is this study about?

This study is designed for individuals who have a specific type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced. This means the cancer has either spread locally in a way that makes surgery impossible, or it has spread to other parts of the body. Importantly, this study is for those whose cancer has already been treated with standard chemotherapy and a type of treatment called immunotherapy, but has unfortunately started to grow again.

The main aim of this study is to investigate new treatment options. Patients taking part will be assigned randomly to one of two groups. One group will receive a combination of two established anti-cancer medicines: paclitaxel and bevacizumab. The other group will receive these same two medicines, plus an additional drug called atezolizumab. Atezolizumab is a type of immunotherapy that helps your body's immune system fight cancer cells.

By comparing these two treatment approaches, the researchers hope to determine if adding atezolizumab to the paclitaxel and bevacizumab combination can help patients live longer without their cancer getting worse. The study is particularly interested in whether a significant number of patients (at least 66%) on the three-drug treatment can achieve this goal for at least six months. This information is crucial for developing more effective treatments for people facing advanced NSCLC.

Key takeaways

This study is for advanced non-small cell lung cancer that has worsened after previous treatments.
It compares two treatment combinations: two drugs versus three drugs (adding atezolizumab).
The aim is to see if the three-drug combination can prevent cancer from growing for longer.
Participation involves being randomly assigned to a treatment group.
You will be closely monitored throughout the study.
You can leave the study at any time.

Who may be eligible?

To join this study, you would need to be at least 18 years old and generally well enough to take part, meaning you can carry out most of your daily activities without much trouble. You must have advanced non-small cell lung cancer that doctors have confirmed under a microscope, and it must be a type called 'non-squamous'. We would also need to check that your cancer has already been treated with both immunotherapy and platinum-based chemotherapy, and that it has unfortunately started to grow again after these treatments.

It's important that you don't have any medical reasons that would prevent you from safely receiving the medicine called bevacizumab. Before you start, doctors will need to make sure they have a sample of your tumour tissue that can be used for special tests. This helps them understand more about your cancer and how it might respond to treatment.

Finally, for doctors to properly measure how your cancer is responding to treatment, you need to have at least one measurable tumour spot in your body. This allows them to track any changes accurately throughout the study.

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 (non-squamous type)?
Has your cancer grown after receiving both immunotherapy and platinum-based chemotherapy?
Are you generally well enough for daily activities and have no major health issues preventing specific drug use?
Do you have a tumour that doctors can measure to track treatment effects?
Would you be willing to provide a tumour tissue sample for testing (if not already available)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two treatment groups. This is like flipping a coin, so neither you nor your doctor can choose which group you join. Treatment will continue until your cancer starts to grow, if the side effects become too difficult to manage, or if you decide you no longer want to participate. In some cases, if you're in the group receiving atezolizumab, and your doctor thinks it's still helping, you might be able to continue taking it even if your cancer shows some signs of progression.

You will have regular appointments for check-ups, blood tests, and scans to monitor your health and how well the treatment is working. This study is taking place in around 40 different hospitals, and it aims to include about 156 patients in total. The specific number of visits and tests will be explained in detail by the study team, and you always have the right to stop participating at any time.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive new treatments that are not yet widely available, which could potentially help manage your cancer. However, there are no guarantees that the treatment will be effective for you, and it might not be better than standard care. All medicines have potential side effects, and the drugs used in this study (paclitaxel, bevacizumab, and atezolizumab) can cause various side effects, which will be carefully explained to you by the study team. You will be closely monitored for these effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (44)

CHU Amiens
Verified postcode
Amiens, France
CHU d'Angers
Verified postcode
Angers, France
CH Avignon
Verified postcode
Avignon, France
CH Côte Basque
Verified postcode
Bayonne, France
CHU Besançon - Hôpital J. MINJOZ
Verified postcode
Besançon, France
Polyclinique Bordeaux Nord Aquitaine
Verified postcode
Bordeaux, France
Hôpital APHP Ambroise Paré
Verified postcode
Boulogne, France
CHU Côte de Nacre
Verified postcode
Caen, France
CH Cholet
Verified postcode
Cholet, France
CHU Gabriel Montpied
Verified postcode
Clermont-Ferrand, France
CH Pasteur
Verified postcode
Colmar, France
Centre Hospitalier Intercommunal Créteil CHIC
Verified postcode
Créteil, France

Common questions

What is non-small cell lung cancer (NSCLC)?

It's the most common type of lung cancer. 'Advanced' means it has spread and can't be fully removed with surgery. This study focuses on NSCLC that has grown after initial treatments.

What are paclitaxel, bevacizumab, and atezolizumab?

They are all medicines used to treat cancer. Paclitaxel is a chemotherapy drug, bevacizumab helps stop blood vessel growth to tumours, and atezolizumab is an immunotherapy that works with your immune system to fight cancer.

What does 'randomised' mean in a study?

It means you are assigned to a treatment group by chance, like drawing names from a hat. This helps ensure the study results are fair and unbiased.

What is 'progression free survival'?

It means the length of time a person lives with cancer without their cancer getting worse or growing. Researchers want to see if treatments can extend this time.

Can I stop being in the study whenever I want?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.