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Active not recruitingNAINTERVENTIONAL

Adjuvant Chemotherapy in Patients With Intermediate or High Risk Stage I or Stage IIA Non-squamous Non-Small Cell Lung Cancer: AIM-HIGH (Adjuvant Intervention in Molecular High Risk Patients)

This study aims to find the best way to treat people with early-stage (Stage I or IIA) non-small cell lung cancer after their tumour has been removed by surgery. While some patients in this group have a significant risk of the cancer returning, it's been unclear whether extra chemotherapy after surgery is helpful. This trial uses a new 14-gene test to identify patients who are at an intermediate or high risk of their cancer coming back. The study will compare two approaches for these higher-risk patients: either continuing with regular check-ups, or having additional chemotherapy after their operation. The goal is to see which approach leads to better results for patients.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
Razor Genomics
Enrolment target
420
Start
11 Sep 2020
Estimated completion
15 May 2027

What is this study about?

When someone has early-stage non-small cell lung cancer, the main treatment is often surgery to remove the tumour. However, for some patients, there's a chance the cancer could return, even if all visible signs of it are gone after the operation. This is because tiny cancer cells, too small to be seen, might still be in the body.

Previously, it's been a bit unclear whether giving extra chemotherapy after surgery helps people with Stage I or IIA lung cancer. Some studies haven't shown a clear benefit, but we know a significant number of these patients still face a high risk of their cancer coming back within five years. Because of this, some cancer experts have started suggesting that extra chemotherapy might be a good idea for patients who are thought to be at a particularly high risk.

This study uses a new, special test called a '14-Gene Prognostic Assay'. This test can look at your tumour after surgery and help doctors work out if you are at an intermediate or high risk of the cancer returning. The 'AIM-HIGH' study wants to find out if giving chemotherapy to these specific higher-risk patients, identified by this gene test, leads to better outcomes compared to just keeping a close eye on them with regular check-ups after surgery. By comparing these two approaches, the study hopes to find the best way to care for patients in this situation.

Key takeaways

  • This study compares two ways to manage early-stage lung cancer after surgery.
  • It focuses on patients whose cancer is considered higher risk using a new gene test.
  • One group will have extra chemotherapy, the other will have regular check-ups.
  • The goal is to find the best approach to prevent the cancer from returning.
  • Participation involves being randomly assigned to a treatment group and having long-term follow-up.

Who may be eligible?

To join this study, you would need to be 18 years old or older and have had surgery to completely remove a non-squamous non-small cell lung cancer that was either Stage I or IIA. Your general health should be good enough to potentially receive chemotherapy, and you would need to be willing to be put into one of the study groups by chance (randomised).

You would not be able to join if your cancer was a different type (like pure squamous, small cell, or neuroendocrine lung cancer), or if it was more advanced than Stage IIA. If you are pregnant or breastfeeding, or if you have certain other serious health conditions that would make chemotherapy unsafe, you also wouldn't be able to take part. Having certain other cancers recently or being on other experimental drugs could also stop you from joining.

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. Are you 18 years old or older?
  2. Have you had surgery to completely remove non-squamous non-small cell lung cancer (Stage I or IIA)?
  3. Are you generally healthy enough for chemotherapy?
  4. Would you be willing to be put into a study group by chance?
  5. Are you generally available for follow-up appointments over about five years?
Answer every question to see your result.

What does participation involve?

If you decide to take part, your doctor will first check if you meet all the requirements for the study. If you do, and after discussing everything and giving your consent, you would then be randomly assigned to one of two groups. One group would receive additional chemotherapy after your surgery, and the other group would continue with regular check-ups (radiographic surveillance). The specific type and timing of chemotherapy would be discussed with you.

Both groups would have regular follow-up appointments and scans over a period of about five years to keep an eye on your health and check for any signs of the cancer returning. You would need to be willing to attend these appointments as scheduled. The study involves collecting information about your treatment and health outcomes during this time.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving treatment under close medical supervision and contributing to medical knowledge that could help future patients. However, there are also potential risks involved, especially with chemotherapy which can have side effects. You might experience side effects from the chemotherapy, or find that the treatment doesn't benefit you, or that the regular check-up approach isn't as effective as chemotherapy. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (49)

  • Leonard Cancer Institute
    Verified postcode
    Mission Viejo, United States
  • UC Davis Comprehensive Cancer Center
    Verified postcode
    Sacramento, United States
  • Providence Medical Foundation Santa Rosa
    Verified postcode
    Santa Rosa, United States
  • Sarah Cannon- FCS South
    City only
    Fort Meyers, United States
  • Sarah Cannon- FCS North
    City only
    Petersburg, United States
  • Sarah Cannon- FCS Panhandle
    Verified postcode
    Tallahassee, United States
  • Sarah Cannon- FCS East
    Verified postcode
    West Palm Beach, United States
  • Baptist Health Lexington
    Verified postcode
    Lexington, United States
  • Baptist Health Louisville
    Verified postcode
    Louisville, United States
  • Mercy Hospital Joplin Missouri
    Verified postcode
    Joplin, United States
  • Mercy Oncology Research St. Louis
    Verified postcode
    St Louis, United States
  • Hackensack Meridian Health
    Verified postcode
    Neptune City, United States

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer, and 'non-squamous' refers to a specific type of this cancer seen under a microscope.

What does 'Stage I or IIA' mean?

These are early stages of lung cancer, meaning the cancer is relatively small and hasn't spread far from its original site in the lung.

What is adjuvant chemotherapy?

This is extra chemotherapy given after surgery to try and kill any remaining tiny cancer cells that might not have been removed by the operation.

What is the '14-Gene Prognostic Assay'?

It's a special laboratory test that looks at specific genes in your cancer tissue to help predict if your cancer is likely to return after surgery.

Why is this study important?

It helps doctors understand if giving chemotherapy to certain higher-risk patients with early-stage lung cancer, identified by a gene test, is better than just having regular check-ups.

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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