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Tyrosine Kinase Inhibitor

Osimertinib + Savolitinib for Lung Cancer (SAVANNAH Trial)

Phase 2

Waitlist Available

Led By Lecia V Sequist, MD MPH

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG/WHO performance status of 0 or 1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.

Adequate haematological function defined as: Absolute neutrophil count ≥1500/μL; Haemoglobin ≥9 g/dL (no transfusion in the past 2 weeks); Platelets ≥100,000/μL (no transfusion in the past 10 days).

Must not have

Acute coronary syndrome

Prior or current treatment with savolitinib or another MET inhibitor (eg, foretinib, crizotinib, cabozantinib, onartuzumab, capmatinib).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up blood samples collected at screening within 28 days before the first dose of study treatment; on day of first dose of study treatment; at discontinuation 7 days after last dose of study treatment. (one cycle = 28 days)

Summary

This trial will test whether adding savolitinib to osimertinib can help patients with EGFRm+ and MET+ NSCLC that has progressed after osimertinib treatment.

Who is the study for?

Adults with advanced non-small cell lung cancer (NSCLC) that has specific mutations (EGFRm+) and MET amplification/overexpression, who have seen their cancer progress after treatment with osimertinib. They must be in good physical condition, not have severe heart issues or uncontrolled hypertension, and women of childbearing potential must use effective contraception.

What is being tested?

The trial is testing the effectiveness of combining two drugs: osimertinib and savolitinib versus a placebo for patients whose NSCLC has worsened despite previous osimertinib treatment. The goal is to see if this combination can help control the disease better.

What are the potential side effects?

Possible side effects include diarrhea, rash, dry skin, nail toxicity associated with osimertinib; fatigue, nausea and increased blood creatinine related to savolitinib; plus general risks like infection risk increase due to weakened immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself, haven't gotten worse in 2 weeks, and am expected to live at least 3 more months.

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My blood counts meet the required levels for treatment.

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My condition worsened after osimertinib treatment.

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My liver tests are within the required range.

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I can provide a tumor sample for testing that meets specific conditions.

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My advanced lung cancer has a specific EGFR mutation sensitive to certain treatments.

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I am 18 years or older (20 or older if I am in Japan).

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My cancer has worsened despite taking osimertinib.

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My cancer shows high MET levels after first-line osimertinib treatment.

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I agree to use barrier contraception during and for 6 months after the study.

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I have only been treated with osimertinib for my advanced cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a recent heart attack or severe chest pain.

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I have been treated with a MET inhibitor like savolitinib.

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I have a history of serious liver disease or cirrhosis.

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I have been diagnosed with moderate to severe heart failure.

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I have had lung conditions that needed steroid treatment.

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I have had a stroke or a transient ischemic attack.

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I do not have an active serious infection like TB or HIV.

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I do not have active hepatitis B or C, tuberculosis, or HIV.

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I have had a heart attack recently.

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I am allergic to osimertinib, savolitinib, or similar drugs.

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I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.

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My heart's electrical activity is normal, with no significant abnormalities.

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I have unstable chest pain.

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I am not taking strong CYP3A4 inducers or CYP1A2 inhibitors, including St John's Wort.

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I have been treated with a specific lung cancer medication other than osimertinib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening within 28 days before first dose; at first dose; 7 days after last dose. tumour tissue collected during pre-screening and at treatment discontinuation 7 days after last dose. (one cycle = 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening within 28 days before first dose; at first dose; 7 days after last dose. tumour tissue collected during pre-screening and at treatment discontinuation 7 days after last dose. (one cycle = 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening within 28 days before first dose; at first dose; 7 days after last dose. tumour tissue collected during pre-screening and at treatment discontinuation 7 days after last dose. (one cycle = 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR) by investigator assessment in accordance with RECIST 1.1

Secondary study objectives

AEs, SAEs and discontinuation rate due to AEs, as characterized and graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event [CTCAE] v5.

Duration of Response (DoR) assessed by BICR in accordance with RECIST 1.1

Duration of Response (DoR) by investigator assessment in accordance with RECIST 1.1.

+9 more

Other study objectives

CNS PFS by BICR assessments in accordance with RECIST 1.1

Disease relevant or response markers in tumour tissue and circulating tumour DNA/RNA including but not limited to EGFR mutations and MET amplifications.

EQ-5D-5L

+6 more