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Small Molecule Kinase Inhibitor
Savolitinib + Osimertinib for Non-Small Cell Lung Cancer (SAFFRON Trial)
Phase 3
Recruiting
Led By Shun Lu, Prof,MD,PhD,
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy
MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 55 months post first subject randomized
Awards & highlights
SAFFRON Trial Summary
This trial will compare the effects of two cancer treatments in people with EGFR-mutated NSCLC that has progressed despite treatment with osimertinib.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has worsened despite osimertinib treatment. Participants must have a specific EGFR mutation, MET overexpression/amplification, and be in good physical condition (ECOG 0 or 1). They cannot join if they have brain metastases, heart issues, liver cirrhosis, prior MET inhibitor use, serious infections like HIV/HBV/HCV, or recent live vaccines.Check my eligibility
What is being tested?
The study compares the effectiveness of savolitinib combined with osimertinib against standard platinum-based chemotherapy in treating NSCLC after osimertinib failure. It aims to determine which treatment is safer and works better for patients who meet certain genetic criteria.See study design
What are the potential side effects?
Potential side effects include typical chemotherapy-related issues such as nausea, fatigue, blood count changes; savolitinib may cause swelling or pain at the injection site and possible liver enzyme alterations. Osimertinib can lead to diarrhea and skin reactions.
SAFFRON Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer cannot be cured with surgery or radiation.
Select...
My cancer showed MET overexpression after treatment with osimertinib.
Select...
I can provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample.
Select...
My cancer progressed after treatment with osimertinib.
Select...
I am fully active or can carry out light work.
Select...
My cancer has a specific EGFR mutation.
SAFFRON Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 55 months post first subject randomized
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 55 months post first subject randomized
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on osimertinib.
Secondary outcome measures
Disease control rate (DCR) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
Duration of response (DoR) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
Objective response rate (ORR) savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
+7 moreSAFFRON Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Savolitinib + OsimertinibExperimental Treatment2 Interventions
300 mg savolitinib BID plus 80 mg osimertinib QD
Group II: ChemotherapyActive Control3 Interventions
Pemetrexed (500 mg/m2) with either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles (Q3W) for 4 cycles, followed by pemetrexed maintenance (500 mg/m2) Q3W
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010
Savolitinib
2019
Completed Phase 1
~110
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,613,036 Total Patients Enrolled
Shun Lu, Prof,MD,PhD,Principal InvestigatorShanghai Chest Hospital, Shanghai JiaoTong University, #241 Huai Hai Road (west), Shanghai, China.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer cannot be cured with surgery or radiation.My cancer showed MET overexpression after treatment with osimertinib.I can provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample.I have or had cancer spread to the lining of my brain and spinal cord.You have a disease that can be measured using specific guidelines called RECIST 1.1.I am not taking strong drugs or supplements that affect liver enzymes.My brain or spinal tumors are stable and not causing symptoms.I have a history of serious liver disease or cirrhosis.I do not have heart problems or ECG changes that could affect my heart rhythm.My lung cancer is mainly squamous or is small cell type.I have had lung inflammation that needed steroids.I have been treated with savolitinib or similar drugs.My cancer progressed after treatment with osimertinib.I do not have any serious active infections like TB, HIV, or hepatitis.I am at least 18 years old, or 20 if I live in Japan.I have not received any live vaccines in the last 30 days.My blood, liver, kidney, heart functions, and clotting are all within normal ranges.I am fully active or can carry out light work.I don't have severe side effects from previous treatments, except for possible hair loss, mild nerve pain, or low but acceptable hemoglobin levels.I have been treated with an EGFR inhibitor, but not Osimertinib.My cancer has a specific EGFR mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Chemotherapy
- Group 2: Savolitinib + Osimertinib
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
When might Savolitinib be cleared for public use in the United States?
"Savolitinib was given a safety score of 3. This is because it is a Phase 3 trial, so there is already some evidence that the drug works and that it doesn't cause too many adverse effects."
Answered by AI
Are there several hospitals running this study in different cities?
"To make participating in this trial as convenient as possible for patients, the locations have been spread out across 14 different sites. Some of these include Nashville, Orlando and Evergreen Park."
Answered by AI
Are those under the age of 65 years old able to participate in this research?
"This study includes patients that are aged 18 or older, with the maximum age limit set at 130 years old."
Answered by AI
Which patients would be a good fit for this clinical trial?
"This study is enrolling 324 people with carcinoma aged 18 and 130. Most notable, patients are required to meet the following criteria: • Participant must be ≥18 years (≥ 20 years of age in Japan) at the time of signing the informed consent. All genders are permitted.• Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy.• Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy.• Mandatory provision of FFPE tumour"
Answered by AI
Are researchers looking for more participants in this trial?
"This trial is still recruiting patients, if you are interested. The listing on clinicaltrials.gov shows that the study was first posted on 8/3/2022 and has been edited most recently on 11/7/2022."
Answered by AI
How many people are enrolled in the trial?
"In order to move forward with this study, we need 324 individuals who meet the pre-determined inclusion criteria. These patients will be recruited from different locations such as Research Site in Nashville, Tennessee and Rutgers Cancer Institute of New jersey (CINJ) in Orlando, Illinois."
Answered by AI
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