RECRUITING

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

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Conditions

CarcinomaNon-Small-Cell LungSavolitinibOsimertinibEGFRAmplifiedMetastaticMET DrivenNSCLCoverexpressed

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Clinical study to investigate the efficacy and safety 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 NSCLC who have progressed on treatment with Osimertinib.

Official 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).

Quick Facts

Study Start:2022-08-03
Study Completion:2026-12-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05261399

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 130 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses.
  2. * Participant must be ≥18 years (≥ 19 years of age in South Korea) at the time of signing the informed consent. All genders are permitted.
  3. * Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy.
  4. * Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M.
  5. * Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy.
  6. * Mandatory provision of FFPE tumour tissue.
  7. * MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment.
  8. * Measurable disease as defined by RECIST 1.1.
  9. * Adequate haematological, liver, renal and cardiac functions, and coagulation parameters.
  10. * ECOG performance status of 0 or 1.
  1. * Predominant squamous NSCLC, and small cell lung cancer.
  2. * Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib.
  3. * Prior or current treatment with savolitinib or another MET inhibitors.
  4. * Spinal cord compression or brain metastases, unless asymptomatic and are stable.
  5. * History or active leptomeningeal carcinomatosis.
  6. * Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 and prior platinum-therapy related Grade 2 neuropathies with the exception of alopecia and haemoglobin ≥ 9.0 g/dL.
  7. * Active/unstable cardiac diseases currently or within the last 6 months, clinically significant ECG abnormalities, and/or factors/medications that may affect QTc intervals.
  8. * History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement.
  9. * Known serious active infection including, but not limited to, tuberculosis, or HIV, HBV or HCV or gastrointestinal disease.
  10. * Receipt of live attenuated vaccine (including against COVID-19) within 30 days prior to the first dose of study intervention.
  11. * Past medical history of ILD, drug-induced ILD, radiation pneumonitis, which required steroid treatment, or any evidence of clinically active ILD.
  12. * Participants currently receiving medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP)3A4 or strong inhibitors of CYP1A2.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com
AstraZeneca Lung Cancer Study Locator Service
CONTACT
1-884-432-3892
az-lcsl@careboxhealth.com

Principal Investigator

Shun Lu, Prof,MD,PhD,
PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital, Shanghai JiaoTong University, #241 Huai Hai Road (west), Shanghai, China.

Study Locations (Sites)

Research Site
La Jolla, California, 92093
United States
Research Site
Orange City, Florida, 32763
United States
Research Site
Orlando, Florida, 32804
United States
Research Site
Honolulu, Hawaii, 96819
United States
Research Site
Evergreen Park, Illinois, 60805
United States
Research Site
Boston, Massachusetts, 02114
United States
Research Site
Boston, Massachusetts, 02215
United States
Research Site
Detroit, Michigan, 48202
United States
Research Site
Florham Park, New Jersey, 07932
United States
Research Site
New Brunswick, New Jersey, 08903
United States
Research Site
New York, New York, 10032
United States
Research Site
Canton, Ohio, 44718
United States
Research Site
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: AstraZeneca

  • Shun Lu, Prof,MD,PhD,, PRINCIPAL_INVESTIGATOR, Shanghai Chest Hospital, Shanghai JiaoTong University, #241 Huai Hai Road (west), Shanghai, China.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-03
Study Completion Date2026-12-17

Study Record Updates

Study Start Date2022-08-03
Study Completion Date2026-12-17

Terms related to this study

Keywords Provided by Researchers

  • Savolitinib
  • Osimertinib
  • EGFR
  • Amplified
  • Metastatic
  • MET Driven
  • carcinoma
  • NSCLC
  • overexpressed

Additional Relevant MeSH Terms

  • Carcinoma
  • Non-Small-Cell Lung