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

Sponsor
Hutchison Medipharma Limited
Study ID
NCT05009836
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Savolitinib — DRUG
    Subjects will receive Savolitinib 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally, 21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
  • Placebo — DRUG
    Subjects will receive Placebo 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally, 21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

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

Start date
Sep 6, 2021
Status verified
Jun 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
    Savolitinib 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally
  • Placebo Comparator: placebo
    Placebo 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally

Primary Outcome Measure

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

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