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Tyrosine Kinase Inhibitor

Osimertinib + Savolitinib for Lung Cancer (SAVANNAH Trial)

Phase 2

Recruiting

Led By Myung-Ju Ahn, MD

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).

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)

Awards & highlights

SAVANNAH Trial 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.Check my eligibility

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.See study design

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.

SAVANNAH Trial 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.

SAVANNAH Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

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

Side effects data

From 2022 Phase 2 trial • 17 Patients • NCT03434418

76%

Diarrhea

53%

Fatigue

41%

Anorexia

41%

Weight loss

35%

Dyspnea

29%

Abdominal pain

29%

Vomiting

24%

Maculopapular rash

24%

Acneiform rash

24%

Cough

Thromboembolic event

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Osimertinib

SAVANNAH Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: osimertinib + savolitinibExperimental Treatment2 Interventions

osimertinib + savolitinib

Group II: placebo + savolitinibPlacebo Group2 Interventions

placebo + savolitinib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

osimertinib

2018

Completed Phase 2

~150

savolitinib

2014

Completed Phase 2

~1000

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,267 Previous Clinical Trials

288,606,621 Total Patients Enrolled

Hutchison MediPharmaUNKNOWN

Myung-Ju Ahn, MDPrincipal InvestigatorSamsung Medical Centre Sungkyunkwan University School of Medicine

2 Previous Clinical Trials

629 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare facilities are hosting this research experiment?

"This trial is currently available at 13 medical locations, including Toronto, La Jolla and Brooklyn. To minimize travel requirements for participants, it's best to select the clinic nearest your residence."

Answered by AI

Has osimertinib received the regulatory green light from the FDA?

"Our team's appraisal of osimertinib's safety yielded a rating of 2, as data exists to back up its protection but it has yet to be determined if the medication is effective."

Answered by AI

Are there still open slots available for participants in this research endeavor?

"Affirmative, according to the information posted on clinicaltrials.gov this medical trial is accepting patients. The study debuted on September 1st 2019 and was last modified November 28th 2022. Recruitment of 360 individuals from 13 sites is required for completion of the trial."

Answered by AI

Have there been any precedential investigations related to osimertinib?

"Osimertinib was first trialed in 2013 at Research Site, and now boasts 2734 completed studies. Of the 112 active investigations of this medication, many are situated around Toronto, Ontario."

Answered by AI

Is this a pioneering trial that is attempting to break new ground?

"Currently, 112 clinical trials for osimertinib are being conducted in 1080 cities and 51 countries. Since its first trial sponsored by AstraZeneca commenced in 2013 with 603 participants, 2734 studies have been successfully completed."

Answered by AI

How many individuals are joining this research endeavor?

"Affirmative. Information available on clinicaltrials.gov indicates that this trial is actively enrolling, with the first listing posted on September 1st 2019 and most recently updated in November 28th 2022. The research project aims to recruit 360 patients from 13 different medical centres."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Targeting MET in EGFR Resistance in Non-small-cell Lung Cancer—ready for Daily Practice?

Schmid, Sabine, Martin Früh, and Solange Peters. 2020. “Targeting MET in EGFR Resistance in Non-small-cell Lung Cancer—ready for Daily Practice?”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(19)30859-9.

clinicaltrials.govStudy

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

2019. "Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03778229.