Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification

Sponsor
Hutchison Medipharma Limited
Study ID
NCT05015608
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Savolitinib + Osimertinib — DRUG
    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.
  • Pemetrexed + Cisplatin /Carboplatin — DRUG
    Pemetrexed combined with platinumon on Day 1 of 21day cycles (every 3 weeks)

Study Details

This study will look at how effective the study drug(Savolitinib combined with Osimertinib) versus Pemetrexed combined with platinum in treatment of patients with locally advanced or metastatic NSCLC with MET amplification after failure of the first-line EGFR inhibitor therapy.

Key Dates

Start date
Nov 22, 2021
Status verified
May 2026
Primary completion
Aug 22, 2025
Completion
Aug 22, 2025

Study Design

Enrollment
216 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Savolitinib + Osimertinib
    Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks)
  • Active Comparator: Pemetrexed combined with platinum
    Pemetrexed combined with platinumon on Day 1 of 21day cycles (every 3 weeks)

Primary Outcome Measure

PFS [ Time Frame: 5 months after the last patient enrolled ]

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