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Active not recruitingPHASE3INTERVENTIONAL

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

This study is for people with a common type of lung cancer called non-small cell lung cancer that has specific genetic changes and has started to grow again after treatment with a medicine called osimertinib. Researchers want to find out if a new combination of medicines, savolitinib and osimertinib, is more effective and safer than standard chemotherapy (like Pemetrexed, Cisplatin, or Carboplatin). The study aims to see if this new treatment can help control the cancer for longer. About 324 people will take part, with half receiving the new combination and the other half receiving chemotherapy. Participants will continue treatment as long as it's helping and not causing too many side effects.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
345
Start
03 Aug 2022
Estimated completion
23 Nov 2026

What is this study about?

This research study is about a type of lung cancer called non-small cell lung cancer, which is the most common kind. Specifically, it focuses on people whose cancer has certain genetic changes (called EGFR mutations and MET changes) and has previously been treated with a drug called osimertinib, but the cancer has started to grow again.

The main goal of the study is to see if a new combination of two medicines, savolitinib and osimertinib, can be a better treatment than the standard chemotherapy drugs doctors usually use in this situation. Researchers want to compare how well these treatments work in shrinking the cancer or stopping its growth, and also to understand any side effects they might cause. Finding more effective treatments is really important for people living with this type of lung cancer.

By taking part, you would be helping doctors learn more about how to treat this advanced lung cancer. The study will carefully monitor particpants to understand the effects of the treatments. It's a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available.

Key takeaways

  • This study compares a new drug combination to standard chemotherapy for advanced lung cancer.
  • It's for people whose non-small cell lung cancer (with specific gene changes) has progressed after osimertinib.
  • The new combination involves savolitinib and osimertinib.
  • About 324 people will take part, randomly assigned to one of two treatment groups.
  • The main goals are to check how well the treatments work and their potential side effects.

Who may be eligible?

To join this study, you generally need to be at least 18 years old and have non-small cell lung cancer with specific genetic changes (EGFR mutation and changes in a gene called MET) that cannot be cured by surgery or radiation. Your cancer must have sadly gotten worse after being treated with osimertinib recently. Doctors will also need to be able to measure your cancer on scans and you should be generally well enough to take part, as assessed by your doctor.

There are also some reasons why you might not be able to join. For instance, if you have a different type of lung cancer, or if you've already had certain other treatments (like savolitinib or other similar drugs) or other specific types of osimertinib. You also can't have certain serious heart problems, brain or spinal problems that aren't stable, or unstable infections like HIV. Your doctor will carefully check all these points to make sure the study is right and safe 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.

  1. Are you 18 years old or older?
  2. Do you have non-small cell lung cancer that cannot be cured by surgery?
  3. Has your lung cancer grown after recent treatment with osimertinib?
  4. Do your cancer cells have specific genetic changes (EGFR and MET)?
  5. Are you generally well and able to perform daily tasks?
  6. Do you have stable heart health and no severe infections?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups: either receiving the new combination of savolitinib and osimertinib, or receiving standard chemotherapy (like Pemetrexed with Cisplatin or Carboplatin). You won't get to choose which group you're in, as this helps ensure fair comparisons.

You'll take your study medicine or receive chemotherapy according to a schedule decided by the research team. This will involve regular visits to the clinic for medical check-ups, blood tests, and scans to see how the treatment is working and monitor for any side effects. You will continue treatment for as long as it is helping to control your cancer and you are tolerating it well. The total time you spend on the study will depend on how you respond to the treatment, but you will be monitored closely throughout.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments before they are widely available, which could potentially help control your cancer. However, there's no guarantee the new treatment will work better than standard care, and it might not help everyone. Like all medicines, the study treatments can have side effects, which could be mild or more serious. The study team will monitor you closely for any unwanted effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (226)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Orlando, United States
  • Research Site
    Verified postcode
    Honolulu, United States
  • Research Site
    Verified postcode
    New Brunswick, United States
  • Research Site
    Verified postcode
    New York, United States
  • Research Site
    Verified postcode
    Nashville, United States
  • Research Site
    Verified postcode
    Buenos Aires, Argentina
  • Research Site
    Unverified
    CABA, Argentina
  • Research Site
    Verified postcode
    Florida, Argentina
  • Research Site
    Verified postcode
    La Rioja, Argentina
  • Research Site
    Verified postcode
    Rosario, Argentina
  • Research Site
    Verified postcode
    Rosario, Argentina
  • Research Site
    Verified postcode
    San Miguel de Tucumán, Argentina

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer, and there are different kinds within this group. This study focuses on specific genetic changes in this cancer.

What does 'EGFR mutated' mean?

It means your cancer cells have a particular change in a gene called EGFR, which often helps the cancer grow. Osimertinib targets this change.

What does 'MET-overexpressed and/or amplified' mean?

This refers to another specific change in a gene called MET, which can sometimes make lung cancer resistant to treatments like osimertinib.

What is 'platinum-based doublet chemotherapy'?

It's a standard type of cancer treatment using two chemotherapy drugs, one of which contains platinum, to kill cancer cells.

Will I know if I'm getting the new combination or chemotherapy?

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

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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