All studies
Active not recruitingPHASE2, PHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

This research is a large study (Phases 2 and 3) looking into new ways to treat non-small cell lung cancer that has spread or can't be removed by surgery. We are testing different drugs, including targeted therapies and immunotherapy, either alone or in combination. These treatments are designed for people whose cancer has specific genetic changes or a high 'tumour mutational burden', which we find using a special blood test. The main goal is to see how well these new treatments work and if they are safe. This study is open-label, meaning both you and your doctor will know which treatment you are receiving, and it involves many hospitals around the world.

At a glance

Status
Active not recruiting
Phase
PHASE2, PHASE3
Sponsor
Hoffmann-La Roche
Enrolment target
1,000
Start
22 Sep 2017
Estimated completion
31 Oct 2026

What is this study about?

This study is exploring new treatments for a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced or has spread. Sometimes, cancer cells have specific genetic changes that can make them respond better to certain medicines, called targeted therapies. This study uses a special blood test to find these changes, or to see if the cancer has a high 'tumour mutational burden', which means it might respond well to immunotherapy. The aim is to find out if these new treatments, given alone or in combination, are safe and effective for people with these specific cancer characteristics.

The research includes different types of medicines. Some are 'targeted therapies' which block specific pathways that cancer cells use to grow. Others are 'immunotherapies' which help your body's immune system fight the cancer. By testing these treatments, the study hopes to improve how we treat this kind of lung cancer, potentially leading to more effective options for patients.

This is a 'multi-cohort' study, meaning it looks at different groups of patients at the same time, based on their individual cancer characteristics. It's also 'open-label', so everyone involved knows which treatment is being given. The information gathered from this worldwide study will help doctors understand better which treatments are most helpful for different patients with NSCLC.

Key takeaways

  • Tests new treatments for advanced non-small cell lung cancer.
  • Uses blood tests to find specific cancer characteristics.
  • Compares different targeted therapies and immunotherapies.
  • Aims to find safer and more effective treatment options.
  • Open-label study, meaning you'll know your treatment.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you generally need to have a confirmed diagnosis of non-small cell lung cancer that is advanced or has spread, meaning it cannot be removed by surgery or treated with combined chemotherapy and radiation. You should also be well enough to carry out most of your daily activities, and your cancer needs to be measurable, so doctors can track how it responds to treatment. Your organs, such as your liver and kidneys, need to be working well, and you should have recovered from any previous cancer treatments.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you can't swallow pills. You also wouldn't be able to join if your cancer has spread to your brain and is causing symptoms that aren't controlled, or if you've had another cancer within the last five years (unless it was a very low-risk type). Certain heart conditions, active HIV, or other serious health problems that might make the study drug unsafe or make it hard to understand the study results would also prevent participation.

All participants must also be willing to use effective contraception if they could become pregnant or get someone pregnant during 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.

  1. Do I have advanced or spreading non-small cell lung cancer?
  2. Am I generally well enough to go about my daily activities?
  3. Can I swallow pills, if needed for treatment?
  4. Am I free from serious heart problems or other uncontrolled major illnesses?
  5. Are my kidneys and liver working properly?
  6. Am I willing to use effective birth control if needed?
Answer every question to see your result.

What does participation involve?

If you join this study, you would receive one of the study medications. These could be tablets you take by mouth, or infusions given directly into your bloodstream. You would have regular visits to the clinic for medical check-ups, blood tests, scans (like CT scans) to see how the treatment is working, and to discuss any side effects you might be experiencing. These visits would happen more frequently at the beginning of the study and then might become less often if the treatment is working well. After you finish taking the study medicine, you'll have follow-up visits or contact to monitor your health. The total duration of your participation, including treatment and follow-up, will depend on how your cancer responds to the treatment and your general health, but could last for quite some time.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments that are not yet widely available, and you would be closely monitored by a healthcare team. While there's no guarantee of benefit, the treatment might help to control your cancer. However, all medications have potential side effects, and some might be serious. Your doctors will explain all known risks before you decide to join. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (164)

  • UC Davis
    Verified postcode
    Sacramento, United States
  • Rocky Mountain Cancer Center
    Verified postcode
    Denver, United States
  • SCRI Florida Cancer Specialists South
    Verified postcode
    Fort Myers, United States
  • Florida Cancer Specialist, North Region
    Verified postcode
    St. Petersburg, United States
  • University of Kentucky
    Verified postcode
    Lexington, United States
  • Comprehensive Cancer Centers of Nevada
    Verified postcode
    Las Vegas, United States
  • Dartmouth Hitchcock Medical Center
    Verified postcode
    Lebanon, United States
  • Weill Cornell Medical College-New York Presbyterian Hospital
    Verified postcode
    New York, United States
  • Montefiore Medical Center
    Verified postcode
    The Bronx, United States
  • Oregon HSU
    Verified postcode
    Portland, United States
  • St. Luke's University Health network
    Verified postcode
    Bethlehem, United States
  • Sarah Cannon Research Institute / Tennessee Oncology
    Verified postcode
    Chattanooga, United States

Common questions

What kind of cancer is this study for?

This study is for people with advanced or spreading non-small cell lung cancer.

How do doctors decide which treatment I'd get?

Decisions on treatment will be based on special blood tests that check for specific genetic changes in your cancer.

Will I know which treatment I'm receiving?

Yes, this is an 'open-label' study, meaning you and your doctor will know which treatment you are getting.

What does a 'targeted therapy' mean?

Targeted therapies are medicines that specifically attack cancer cells with certain genetic changes, often causing fewer side effects than traditional chemotherapy.

Can I stop participating in the study if I want to?

Yes, you can leave the study at any time, for any reason, and it won't affect your regular medical care.

How to find out more

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

Discussion

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