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RecruitingLast updated:15 August 2023

SAFFRON: This study is investigating how safe and effective combination targeted therapy is compared to platinum-based doublet chemotherapy in people with EGFR-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic non-small lung cancer who have progressed on treatment with osimertinibA Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Active Comparator Arm or the Experimental Arm. In the Active Comparator Arm, participants will receive chemotherapy consisting of pemetrexed (500mg/m2) with either cisplatin (75mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by pemetrexed maintenance (500mg/m2). These will all be administered by intravenous infusion. In the Experimental Arm, participants will receive 300mg savolitinib twice daily (3 x 100mg) plus 80mg osimertinib once daily.

Treatment Type

Systemic therapy (chemotherapy, hormone therapy or immunotherapy)

Age

People18 - 130

Phase

III

Trial Acronym

SAFFRON

More information

Trial Identifiers

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Commercial Sponsor

AstraZeneca

Scientific Title

A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.
Message

Clinical trials have complex eligibility criteria.

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