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Are you or a loved one interested in participating in a Non-Small Cell Lung Cancer clinical trial?

This is a clinical trial for adults who have been diagnosed with MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on first- or second-line treatment with osimertinib as the most recent therapy.
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Why is the SAFFRON study being done?

The purpose of this study is to determine the direct effect of savolitinib in combination with osimertinib in comparison to platinum-based doublet chemotherapy as it is not confounded by the efficacy of subsequent therapies used after disease progression.
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Who can participate in the SAFFRON study?

You may be eligible to participate in this study if you:
  • Are age 18 and older
  • Have been diagnosed with Non-Small Cell Lung Cancer
  • Have at least one sensitizing EGFR mutation: exon19 deletion, L858R mutation, and/or T790M
  • Radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy
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What happens during the study?

There are 3 study periods: screening, treatment, and follow-up. All aspects of your participation will take place at the study location or at your place of residence.

Screening:

  • You will have health checks and tests to confirm that you are eligible for the study.
  • You will be given an Informed Consent Form that contains all of the information about the study. This is to make sure that you understand the study and ask any questions you may have. If you agree to participate, you will give your permission by signing this form.
  • The screening period is up to 28-days before the first dose of the study drug.

Intervention:

  • During the treatment period, eligible patients will receive the combination of Osimertinib and Savolitinib in 21-day cycles. The study medication will be taken daily by mouth. The treatment period will continue until unacceptable adverse events, documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study (whichever occurs first).

Post-Intervention:

  • Participants will complete an end of treatment visit within 7 days of the final dose
  • Participants will complete a 28-day safety follow-up
  • Participants will complete a progression follow-up
  • Participants will complete a survival follow-up

What treatment will I receive?

You will receive both daily by mouth.
  • Osimertinib and Savolitinib will be administered daily by mouth
  • You will continue your Standard of Care Chemotherapy IV infusion on Day 1 of each 21-day cycle for 4 cycles, followed by pemetrexed maintenance therapy Q3W
What tests will I have?
  • During the study, you may have tests to assess:
  • Blood
  • Heart Activity
  • Urine
  • Medical Imaging
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What else will I have to do?

  • Follow the study staff’s directions regarding the study.
  • Complete all study visits.
  • Tell the study doctor if you have any health updates or changes in medication.

Will I receive compensation for participating in this study?

  • Yes, you will receive $150 upon your completion of the screening visit and $XXX.XX for each subsequent clinical visit.
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GenHarp Clinical Solutions

9730 S. Western Ave., Suite 218
Evergreen Park, IL 60805
872-205-3194

  • 9730 S. Western Ave., Suite 218 Evergreen Park, IL 60805
  • 872-205-3194

Clinical Trials

Clinical Research History
Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Post Covid-19
COPD Clinical Study
Clinical Research History
NSCLC (EFGR/MET)

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