All studies
Active not recruitingPHASE2INTERVENTIONAL

Study of Novel Treatment Combinations in Patients With Lung Cancer

This study is testing new combinations of medicines for people with lung cancer. It’s split into three main groups, called ‘substudies’. Substudy 1 is for people with lung cancer that has spread (stage 4) and who haven't had treatment for it yet. Substudy 2 is for people whose lung cancer has spread and continued to grow, even after they've had other treatments. Substudy 3 is for people with earlier-stage lung cancer (stage 2 or 3) that can be removed by an operation. The main goal is to see how well these new combinations work compared to standard treatments currently used for lung cancer.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Gilead Sciences
Enrolment target
192
Start
16 Mar 2023
Estimated completion
01 Sep 2029

What is this study about?

This research study is called a 'platform clinical trial', which means it's designed to test several new combinations of drugs at the same time to see how well they work for different types of lung cancer. The main aim is to find better ways to treat this condition.

The study is divided into three smaller studies, called 'substudies', each focusing on a different situation. Substudy 1 is for people with lung cancer that has spread to other parts of the body (this is called 'metastatic' or 'advanced' lung cancer) and who have not received treatment for this advanced cancer before. In this group, the researchers want to compare the new drug combinations against the usual treatments currently given.

Substudy 2 is for people with advanced lung cancer that has spread and has gotten worse, even after they've had other treatments. Again, the study will compare the new drug combinations with standard care. Substudy 3 is for people with earlier-stage lung cancer (Stage 2 or 3) that can be removed with surgery. Here, the study will also look at how effective the new combinations are compared to standard treatments before surgery. The researchers will measure how much the cancer shrinks or disappears in response to these new treatments.

Key takeaways

  • Tests new drug combinations for non-small-cell lung cancer.
  • Includes people with advanced, previously treated, and earlier-stage lung cancer.
  • Compares new treatments to standard care currently given.
  • Requires regular hospital visits and check-ups.
  • Aims to find more effective ways to treat lung cancer.

Who may be eligible?

To join this study, you must have lung cancer that is not a specific type called 'small-cell lung cancer'. Your general health and how well you can do daily tasks will be checked; you’ll usually need to be fairly active. Your body's organs, like your liver and kidneys, also need to be working well. People who could have children will need to use effective birth control throughout the study.

Each substudy has additional requirements. For example, if your cancer has certain genetic changes, you might not be eligible for some parts, especially if there are already specific treatments for those changes. If you have advanced cancer, you will need to have some visible cancer that doctors can measure. If you have an active autoimmune disease (where your body attacks itself), a serious infection, or have had recent lung problems like pneumonia, you probably won't be able to take part.

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 you have non-small-cell lung cancer (NSCLC)?
  2. Are you generally feeling well and active (ECOG 0 or 1)?
  3. Are your organs (like liver and kidneys) working well?
  4. Do you not have an active autoimmune disease or a recent serious infection?
  5. If you are female and could become pregnant, are you willing to use birth control?
  6. Do you understand that there are different criteria for each substudy (advanced, treated, or early stage cancer)?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive one of the new drug combinations or a standard treatment. These drugs are given in different ways, some might be infusions (drips) and others might be pills. You will have regular hospital visits for check-ups, blood tests, and scans (like CT scans) to see how the treatment is working and monitor your health. The number of visits and tests will depend on which part of the study you are in and which treatment you receive.

Usually, you'll continue treatment for a period determined by the study doctors, as long as it's helping and not causing too many side effects. After treatment, there will be follow-up appointments to track your health over time. The total length of your participation, including follow-up, could be several months to a couple of years.

Potential risks and benefits

Taking part in a clinical trial offers the chance to try new treatments that are not yet widely available, and you'll receive close medical attention. However, there's no guarantee the new treatments will work better than standard care, and they might have different or unknown side effects. Every medication has potential risks, and these will be explained to you in detail by the study team. You always have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (89)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Arizona Oncology Associates,Substudy-02
    Verified postcode
    Tucson, United States
  • Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03
    Verified postcode
    Fort Wayne, United States
  • Baptist Health Lexington,Substudy-03
    Verified postcode
    Lexington, United States
  • Washington University School of Medicine - Siteman Cancer Center,Substudy-01
    Verified postcode
    St Louis, United States
  • Washington University School of Medicine - Siteman Cancer Center,Substudy-02
    Verified postcode
    St Louis, United States
  • Washington University School of Medicine - Siteman Cancer Center,Substudy-03
    Verified postcode
    St Louis, United States
  • Washington University School of Medicine - Siteman Cancer Center
    Verified postcode
    St Louis, United States
  • Oncology Hematology Care Clinical Trials, LLC,Substudy-01
    Verified postcode
    Cincinnati, United States
  • Oncology Hematology Care Clinical Trials, LLC,Substudy-02
    Verified postcode
    Cincinnati, United States
  • Oncology Associates of Oregon, PC,Substudy-01
    Verified postcode
    Eugene, United States
  • Oncology Associates of Oregon, PC,Substudy-02
    Verified postcode
    Eugene, United States
  • Fundação Pio XII - Hospital de Amor,Substudy-01
    Verified postcode
    Barretos, Brazil

Common questions

What kind of lung cancer is this study for?

This study is for non-small-cell lung cancer (NSCLC), which is the most common type.

What are the main goals of this study?

The main goals are to see how well the new drug combinations work at shrinking or getting rid of cancer, compared to standard treatments.

Are these treatments new?

Yes, the study is testing new combinations of medicines that are not currently standard treatment for these types of lung cancer.

Will I know if I'm getting a new drug or a standard one?

No, in some parts of the study, you might not know, as it's often compared against standard treatment. This is to ensure fair testing of the new drugs.

What does 'metastatic' mean?

'Metastatic' means the cancer has spread from where it started to other parts of the body.

How to find out more

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.