Active not recruitingPHASE2INTERVENTIONAL

Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib

This study, called SAVANNAH, is testing a new way to treat a specific type of advanced lung cancer (non-small cell lung cancer, or NSCLC). It's for people whose cancer has a particular genetic change (EGFRm+) and another specific change called MET+. Participants in this study have already received treatment with a drug called osimertinib, but their cancer has unfortunately started to grow again. Researchers want to see if combining osimertinib with another drug, savolitinib, can help stop the cancer from getting worse. They believe this combination might help overcome the cancer's resistance to previous treatment. You'll either receive the combined treatment or a placebo alongside osimertinib to see if it makes a difference.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AstraZeneca

Enrolment target

367

Start

09 Jan 2019

Estimated completion

31 Dec 2026

Carcinoma

Results

Results from this study

Posted February 2026

Results have been published for this study.

Primary outcome

Objective Response Rate (ORR) by Investigator Assessment; Target Population Analysis Set

Percentage of subjects with a confirmed Objective Response (OR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). OR includes Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in target lesion diameters). OR must be recorded at one visit and confirmed by repeat imaging at least 4 weeks later, with no disease progression between initial and confirmation visits.

Full results on the registry

What is this study about?

This study, known as SAVANNAH, aims to find a better treatment for a specific type of advanced lung cancer. This cancer is called Non-Small Cell Lung Cancer (NSCLC) and has certain genetic changes, specifically EGFRm+ and MET+. These changes mean the cancer cells behave in a particular way.

Many patients with this type of lung cancer are first treated with a drug called osimertinib. However, over time, the cancer can become resistant to this treatment and start to grow again. When this happens, it can be very challenging to find effective new options. Researchers believe that the cancer becoming resistant might be linked to the MET genetic change becoming more active.

So, this study is exploring whether adding a new drug, savolitinib, to osimertinib can help overcome this resistance. Savolitinib is designed to target the MET change. By combining the two drugs, the hope is to stop the cancer from growing further and improve the outlook for patients whose cancer has worsened after their initial osimertinib treatment. It's an important step in trying to find more effective ways to manage this condition.

Key takeaways

Tests a new combination for advanced lung cancer.
For NSCLC with specific genetic changes (EGFRm+ and MET+).
Aims to help when cancer has worsened after osimertinib.
Compares combined treatment with osimertinib plus a placebo.
Close monitoring and support throughout the study.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be at least 18 years old. You need to have been diagnosed with advanced lung cancer (NSCLC) that has specific genetic changes (called EGFRm+ and MET+). This means your doctor has confirmed these changes from your cancer tissue.

It's important that your cancer has already been treated with osimertinib, but has unfortunately started to grow worse. Your doctor will need to provide a recent tumour sample to confirm these changes, especially the MET+ change, to make sure this study is the right fit for you. Also, you must not have received savolitinib or similar drugs before.

Before you start, we'll check your general health, including your blood and liver function, to make sure it's safe for you to take part. Your doctor will also need to be able to measure your cancer on scans to track how well the treatment is working.

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.

Are you 18 years or older?
Do you have advanced Non-Small Cell Lung Cancer with EGFRm+ and MET+ gene changes?
Has your cancer started to grow again after being treated with osimertinib?
Are you generally well enough for a clinical trial (your doctor will check your blood tests and overall health)?
Have you not received a drug similar to savolitinib before?

Answer every question to see your result.

What does participation involve?

If you decide to join the study and are found to be eligible, you will begin treatment on Day 1. You will either receive the combination of osimertinib and savolitinib, or osimertinib with a placebo (a dummy pill that looks like savolitinib). This treatment will involve taking medication in cycles, with each cycle lasting 28 days.

You will continue taking the study medication for as long as it is helping you and you are not experiencing unacceptable side effects. Regular visits will be scheduled for you to see the study team. During these visits, you'll have check-ups, blood tests, and scans to monitor your health and see how the treatment is affecting your cancer. These assessments will help the doctors understand if the treatment is working or if any adjustments are needed. Treatment will stop if your cancer grows, if side effects become too difficult, or if you decide to withdraw from the study.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as gaining access to a new treatment combination before it's widely available, and your health will be very closely monitored. However, there are also potential risks, as the study drugs might cause side effects that are currently unknown or more severe than expected. We can't guarantee that the treatment will be effective for everyone. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (90)

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La Jolla, United States
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Los Angeles, United States
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Sacramento, United States
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Washington D.C., United States
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Baltimore, United States
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Boston, United States
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Rochester, United States
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Brooklyn, United States
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Philadelphia, United States
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Pittsburgh, United States
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Seattle, United States
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Barretos, Brazil

Common questions

What type of lung cancer does this study focus on?

This study is for a specific type of advanced Non-Small Cell Lung Cancer (NSCLC) that has particular genetic changes called EGFRm+ and MET+.

Why are researchers combining these two drugs?

Researchers want to see if combining osimertinib with savolitinib can help overcome the cancer's resistance when it has started to grow again after initial osimertinib treatment.

Will I definitely receive the new drug combination?

You will either receive the combination of osimertinib and savolitinib, or osimertinib with a placebo (a dummy pill). It's a randomised study to fairly compare the effects.

How long will I be in the study?

You'll continue treatment in 28-day cycles for as long as the treatment is helping you and you don't have severe side effects or choose to leave the study.

What kind of tests will I have during the study?

You'll have regular check-ups, blood tests, and scans to monitor your health and see how the treatment is affecting your cancer.