A Phase III Clinical Study on Savolitinib Combined with Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer
A Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Savolitinib Combined with Osimertinib versus Placebo Combined with Osimertinib as the First-line Therapy for Patients with EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
320
Subjects will receive Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Subjects will receive placebo orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse
Guangdong General Hospital
Guangzhou, China
PFS
Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Time frame: 17 months after the last patient enrolled
Safety and tolerability
Incidence and nature of treatment emergent adverse events (TEAE), the other safety variables including physical examination, vital signs and laboratory examinations
Time frame: 17 months after the last patient enrolled
The objective response rate of the tumor (ORR)
the incidence of confirmed complete response or partial response
Time frame: 17 months after the last patient enrolled
The disease control rate (DCR)
the incidence of complete response, partial response and stable disease
Time frame: 17 months after the last patient enrolled
Duration of Response (DoR)
the duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded
Time frame: 17 months after the last patient enrolled
Overall survival (OS)
the time from the date of randomization to the date of death (all causes)
Time frame: 17 months after the last patient enrolled
Time to Response (TTR)
the period from the date of randomization to the date when the criteria for complete response or partial response was first measured (first record shall prevail).
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Time frame: 17 months after the last patient enrolled
PFS
Progression-free survival (PFS) using IRC as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Time frame: 17 months after the last patient enrolled
Development of diagnostic technology
The residual samples may be used for development of MET Companion Diagnostics (CDx)
Time frame: 17 months after the last patient enrolled