RecruitingPHASE2INTERVENTIONAL

Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resectable Non-squamous NSCLC

This research study is for people aged 18 and over with certain types of lung cancer (specifically Stage II, IIIA, or some Stage IIIB non-small cell lung cancer) that can be removed with surgery. We're exploring a pre-surgery treatment that combines a new immunotherapy drug called Atezolizumab with two common chemotherapy drugs, Carboplatin and Nab-Paclitaxel. The main goal is to understand how well this combination shrinks the cancer before surgery and if we can use certain signs in the body to predict which patients will respond best to this treatment. This could help doctors choose the most effective treatment for each person in the future.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Hospital Heidelberg

Enrolment target

Start

07 Jan 2021

Estimated completion

30 Dec 2026

NSCLC Stage II NSCLC, Stage IIIA NSCLC Stage IIIB

What is this study about?

When someone has lung cancer that can be taken out with an operation, surgery is usually the main treatment. Sometimes, chemotherapy is given after surgery to try and stop the cancer from coming back. More recently, doctors have also started giving chemotherapy before surgery (this is called 'neoadjuvant' treatment) to try and shrink the tumour first.

This study is looking at a new approach for people with certain types of lung cancer: Stage II, IIIA, or particular Stage IIIB non-small cell lung cancer that can be removed with an operation. Instead of just chemotherapy before surgery, we are testing a combination of medicines: Atezolizumab (an immunotherapy drug that helps your body’s own immune system fight cancer) along with two standard chemotherapy drugs, Carboplatin and Nab-Paclitaxel. This combined treatment is given before the surgery.

The main aim of this research is to see how much the cancer shrinks after this combination treatment, before the surgery takes place. We're also looking closely at different markers in the body (like parts of your immune system) to see if we can work out why some people respond better than others. Understanding this could help doctors in the future to choose the best treatment for each patient and give them the best chance of a good outcome.

Key takeaways

This study explores a new pre-surgery treatment for certain lung cancers.
It combines an immunotherapy drug with two chemotherapy drugs.
The treatment is given by drip over about 9 weeks before your surgery.
The aim is to shrink the tumour and understand who benefits most.
Participation is voluntary, and you can withdraw at any time.
It's for adults aged 18+ with specific types of surgically removable lung cancer.

Who may be eligible?

This study is for adults, aged 18 or older, who have been diagnosed with a specific kind of lung cancer called non-small cell lung cancer. Specifically, it's for people with Stage II, Stage IIIA, or a particular type of Stage IIIB cancer (where the T3N2 applies). Critically, your cancer must be considered suitable for surgery with the aim of curing it, as confirmed by your surgeon.

You would also need to be generally well and able to perform your usual daily activities, as measured by a score called ECOG 0 or 1. Your heart and lungs need to be healthy enough for the planned lung surgery. We also need to be able to see and measure your cancer on scans, and there must be enough tumour tissue available from your initial diagnosis for special tests.

There are also specific requirements for your blood tests (like blood counts, and how well your kidneys and liver are working) to make sure you're healthy enough to safely receive the study treatments. If you are able to have children, you would also need to agree to use effective contraception during the study and for a period afterwards.

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 non-small cell lung cancer, Stage II, IIIA, or T3N2 Stage IIIB?
Has your surgeon said your cancer can be removed by an operation?
Are you generally well and able to carry out your normal daily activities?
Are your heart and lungs healthy enough for lung surgery?
Are you willing to use effective contraception if you are able to have children?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a combination of three different medicines given by drip into your vein (intravenously). This treatment will happen on specific days over three cycles. Each cycle lasts 21 days (3 weeks). So, for a total of about 9 weeks, you will be receiving these treatments before your surgery. Atezolizumab and Carboplatin are given on day 1 of each 21-day cycle, and Nab-Paclitaxel is given on day 1, day 8, and day 15 of each 21-day cycle. After these three cycles of treatment, you will undergo standard lung surgery, which typically involves removing part or all of the affected lung and checking the surrounding lymph nodes. Throughout the study, you'll have regular hospital visits for check-ups, scans, and blood tests to monitor your health and how the treatment is working. We will follow your progress even after surgery.

Potential risks and benefits

Taking part in a clinical trial like this may offer potential benefits, as you would receive a new combination of treatments that could potentially work better than standard approaches for your type of cancer. However, there are also potential risks involved, as the medicines used can have side effects, and not everyone will respond to the treatment. Your doctors will explain these side effects in detail. It’s important to remember that your participation is completely voluntary; you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Thoraxklinik Heidelberg gGmbH
Verified postcode
Heidelberg, Germany· Recruiting

Common questions

What kind of cancer is this study for?

This study is for specific types of non-small cell lung cancer (Stage II, IIIA, or certain Stage IIIB) that can be removed by surgery.

What medicines will I be given?

You will receive Atezolizumab (an immunotherapy drug), Carboplatin (a chemotherapy drug), and Nab-Paclitaxel (another chemotherapy drug).

How will the medicines be given to me?

All the medicines will be given to you through a drip into your vein (intravenously).

What happens after these treatments?

After three cycles of medicines (about 9 weeks), you will have your planned lung surgery.

What is the main goal of this study?

The main goal is to see how much the cancer shrinks before surgery and if we can predict who will respond best to this treatment combination.

How to find out more

Dirk Jäger, Prof. med.

dirk.jaeger@med.uni-heidelberg.de +49 6221 56 7229 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.