Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC

Sponsor
Hutchmed
Study ID
NCT05009836
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Savolitinib — DRUG
    Savolitinib 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally
  • Placebo — DRUG
    Placebo 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally
  • Osimertinib — DRUG
    Osimertinib 80 mg QD orally

Study Details

A Phase III Clinical Study on Savolitinib Combined with Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer

Key Dates

First listed
Aug 18, 2021
Start date
Sep 6, 2021
Status verified
Sep 2026
Primary completion
May 30, 2028
Completion
May 30, 2028

Study Design

Enrollment
412 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Savolitinib + Osimertinib
    Savolitinib 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally+ Osimertinib 80 mg QD orally ( every 3 weeks)
  • Placebo Comparator: Placebo + Osimertinib
    Placebo 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally+ Osimertinib 80 mg QD orally ( every 3 weeks)

Primary Outcome Measure

PFS [ Time Frame: 17 months after the last patient enrolled ]

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