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RecruitingLast updated: 2 February 2024

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.

Conditions

This trial is treating patients with locally advanced or metastatic non-small lung cancer with EGFR mutation, MET-overexpression and/or amplification

Cancer

Lung Cancers Lung cancer

Age

People18 - 130

Phase

III

Trial Acronym

SAFFRON

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial 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

  • Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses.
  • 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.
  • Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M.
  • Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy.
  • Mandatory provision of FFPE tumour tissue.
  • MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment.
  • Measurable disease as defined by RECIST 1.1.
  • Adequate haematological, liver, renal and cardiac functions, and coagulation parameters.
  • ECOG performance status of 0 or 1.

Exclusion

  • Predominant squamous NSCLC, and small cell lung cancer.
  • Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib.
  • Prior or current treatment with savolitinib or another MET inhibitors.
  • Spinal cord compression or brain metastases, unless asymptomatic and are stable.
  • History or active leptomeningeal carcinomatosis.
  • Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 with the exception of alopecia, haemoglobin ≥ 9.0 g/dL, and Grade 2 prior platinum-therapy related neuropathy.
  • Active/unstable cardiac diseases currently or within the last 6 months, clinically significant ECG abnormalities, and/or factors/medications that may affect QTc intervals.
  • History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement.
  • Known serious active infection including, but not limited to, tuberculosis, or HIV, HBV or HCV or gastrointestinal disease.
  • Receipt of live attenuated vaccine (including against COVID-19) within 30 days prior to the first dose of study intervention.
  • Past medical history of ILD, drug-induced ILD, radiation pneumonitis, which required steroid treatment, or any evidence of clinically active ILD.
  • Participants currently receiving medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP)3A4 or strong inhibitors of CYP1A2.

Inclusion

  • 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.

Exclusion

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

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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