Print this page

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.

Primary Objective:
To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy by assessment of PFS in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.

Secondary Objectives:
- To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy by assessment of OS in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.

- To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy by assessment of PFS in participants with EGFR mutated, MET-overexpressed by IHC, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.

- To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy by assessment of OS in participants with EGFR mutated, MET-overexpressed by IHC, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.

- To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy by assessment of ORR, DoR, DCR, TDT or death, and tumour shrinkage in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.

- To assess participant-reported pulmonary core symptoms of NSCLC in participants treated with savolitinib in combination with 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.

- To evaluate the PK of savolitinib.

Protocol Number: 032207
Phase: Phase III
Applicable Disease Sites: Lung
Drugs Involved: CARBOPLATIN
Osimertinib
PEMETREXED
Savolitinib
Principal Investigator: Missak Haigentz
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Cooperman Barnabas, Livingston
    • Jersey City Medical Center, Jersey City
    • Monmouth Medical Center
    • Newark Beth Israel Medical Center
    • Robert Wood Johnson University Hospital, Hamilton
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.