Savolitinib for Treating Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Patients

Sponsor
Hutchison Medipharma Limited
Study ID
NCT04923945
Phase
PHASE3
Status
Completed

Conditions

  • Non-small Cell Lung Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Savolitinib — DRUG
    Patients meeting the study inclusion criteria will receive Savolitinib \[Savolitinib 600 mg, po, once per day (QD) continuously in patients with baseline weight ≥50 kg, and Savolitinib 400 mg, po, QD in patients with baseline weight \<50 kg\] in 21 day treatment cycle, until disease progression, death, intolerable toxicity or other termination criteria as specified in the protocol, whichever occurs earliest. Or patient will receive Savolitinib \[Savolitinib 300 mg, po, twice per day (BID) continuously in patients with baseline weight ≥50 kg, and Savolitinib 200 mg, po, BID in patients with baseline weight \<50 kg\] in 21 day treatment cycle, until disease progression, death, intolerable toxicity or other termination criteria as specified in the protocol, whichever occurs earliest.

Study Details

Treating Non-small Cell Lung Cancer (NSCLC) Patients with MET exon 14mutations with Savolitinib

Key Dates

Start date
Aug 19, 2021
Status verified
Mar 2025
Primary completion
Nov 30, 2024
Completion
Nov 30, 2024

Study Design

Enrollment
203 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Savolitinib
    NSCLC

Primary Outcome Measure

Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria) [ Time Frame: through study completion, an average of 3 years ]

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