Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients
brief summary
To evaluate the efficacy and safety of glumetinib combined with osimertinib as the first-line treatment for locally advanced or metastatic NSCLC.
detailed description
In the Phase II stage, eligible subjects who have passed screening will be randomly assigned in a 1:1:1 ratio into the Group 1, Group 2, and Group 3 to receive study treatment:
In the Phase III stage, eligible subjects who have passed screening will be randomly assigned in a 1:1 ratio into the test group and the control group to receive the study treatments, and the RP3D obtained from Phase II will be used as the dose of glumetinib for the test group.
Randomization stratification factors include: c-MET status (≥2+, ≥75% and 3+, \<50% vs 3+, ≥50% or FISH positive), and EGFR-sensitive mutation type (19Del vs L858R).
In both the Phase II and Phase III stages, each treatment cycle is every 3 weeks, with continuous treatment until progressive disease (PD) confirmed by the investigator, intolerable toxicity, withdrawal of informed consent by the subject, loss to follow-up, death, or other criteria for terminating treatment as specified in the protocol, whichever occurs first.
official title
A Multicenter Phase II/III Clinical Study on the Efficacy and Safety of Glumetinib Combined With Osimertinib as First-Line Treatment in Non-Small Cell Lung Cancer Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression