Active not recruitingPHASE3INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)

This research is for people with locally advanced non-small cell lung cancer (NSCLC) that doctors can't remove with surgery. This means the cancer is still in the lung area but hasn't spread further. The study will test different new medications to see how effective and safe they are after you've already had chemotherapy and radiotherapy. Researchers will be looking at how these new drugs help patients, specifically those with certain genetic markers in their cancer, to understand if these targeted treatments can improve outcomes for lung cancer patients in the UK.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

Start

01 Nov 2022

Estimated completion

16 Jun 2030

Non-Small Cell Lung Cancer

What is this study about?

This study is about a specific type of lung cancer called non-small cell lung cancer (NSCLC). If you have been diagnosed with NSCLC, you will know that doctors often try to treat it with surgery, but sometimes the cancer is too far along in the lung area to be removed. When this happens, it's called 'locally advanced' and 'unresectable' cancer. Usually, the first step in treating this is a combination of chemotherapy and radiotherapy.

This research is looking at new drug treatments that might be given after you've completed your initial chemotherapy and radiotherapy. The researchers want to find out if these new drugs can help to keep the cancer from growing or coming back, and if they are safe to use. They are particularly interested in patients whose cancer has certain genetic 'markers' which might make them more likely to respond to specific new treatments.

The goal of this study is to find better ways to treat this type of lung cancer and potentially improve the lives of patients in the future. By testing these new medications, we can learn more about how they work and if they could become standard treatments for people with locally advanced NSCLC.

Key takeaways

The study investigates new treatments for locally advanced, non-surgical lung cancer.
Participants must have completed previous chemotherapy and radiotherapy.
Treatments include Alectinib, Entrectinib, and Durvalumab, based on cancer features.
The study aims to find safer and more effective options for lung cancer patients.
Careful monitoring and support will be provided to all participants.

Who may be eligible?

To be considered for this study, you would need to have non-small cell lung cancer that is locally advanced and can't be removed by surgery. You also need to have already completed at least two cycles of chemotherapy alongside or before radiotherapy for your lung cancer, and your cancer should not have worsened during or after these treatments.

Your general health would need to be good enough to take part, including having a body weight of at least 30kg. Doctors would also need to check your cancer cells for specific genetic features, and your overall physical fitness would be assessed. If you are female and could become pregnant, or male, you would need to agree to use contraception during the study. Also, doctors would need a sample of your tumour tissue to do more tests.

The study is open to both men and women aged 18 and over. Before joining, detailed scans and blood tests would be performed to make sure the study treatments are right for you.

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.

Do you have locally advanced non-small cell lung cancer that doctors can't operate on?
Have you already had and completed chemotherapy and radiotherapy for your lung cancer?
Has your cancer not worsened during or after your previous treatments?
Are you generally well enough to take part in a study?
Are you able to provide a sample of your tumour tissue?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given one of the new medications being tested, such as Alectinib, Entrectinib, or Durvalumab. The specific treatment you receive will depend on the genetic features of your cancer. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. You may also be asked to use an electronic device to report on your symptoms and how you are feeling.

The duration of your participation will vary depending on how you respond to the treatment and what the study doctors advise. There will be an initial period of treatment, followed by ongoing monitoring. The research team will explain all the details, including how often you'll need to visit and what tests you'll have, before you decide to take part.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of this study is that you might receive a new treatment that could be more effective than existing options for your type of lung cancer, and your health will be closely monitored. However, there are also potential risks, including side effects from the study medication, which the doctors will explain to you in detail. There is no guarantee that the new treatment will work for you. You are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (45)

Northwest Cancer Specialists, P.C.
Verified postcode
Tigard, United States
Hillman Cancer Center
Verified postcode
Pittsburgh, United States
Peter MacCallum Cancer Centre
Verified postcode
Melbourne, Australia
One Clinical Research
Verified postcode
Nedlands, Australia
UZ Gent
Verified postcode
Ghent, Belgium
Hospital de Cancer de Barretos
Verified postcode
Barretos, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Verified postcode
São Paulo, Brazil
RedSalud Vitacura
Verified postcode
Santiago, Chile
Hunan Cancer Hospital
Verified postcode
Changsha, China
Xinqiao Hospital of Third Military Medical University
Verified postcode
Chongqing, China
Shandong Cancer Hospital
Verified postcode
Jinan, China
Shanghai Pulmonary Hospital
Verified postcode
Shanghai, China

Common questions

What kind of cancer is this study for?

This study is for a type of lung cancer called non-small cell lung cancer (NSCLC) that is locally advanced and cannot be removed with surgery.

What treatments are being tested?

The study is testing new medicines called Alectinib, Entrectinib, and Durvalumab. The one you receive depends on specific features of your cancer.

Do I need to have had other treatments first?

Yes, you must have already completed chemotherapy and radiotherapy for your lung cancer, and it should not have gotten worse afterwards.

What is 'locally advanced, unresectable' cancer?

This means the cancer is still in the lung area but has grown too much or in a difficult place for doctors to remove it with an operation.

Can women who could become pregnant take part?

Yes, if you are a woman who could become pregnant, you would need to agree to use effective contraception during the study.