Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Glumetinib Tablets, Osimertinib Mesylate Tablets, Glumetinib Tablets Placebo.
- Who it may be relevant to
- Registry conditions: Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Glumetinib Tablets
An ATP competitive, highly selective MET receptor tyrosine kinase inhibitor - Drug Osimertinib Mesylate Tablets
3rd EGFR-TKI - Drug Glumetinib Tablets Placebo
Placebo
Primary outcome measures
- Phase 2：ORR as assessed by IRC [Time frame: Up to approximately 30 months after the first participant is enrolled]
Secondary outcome measures (11)
- Phase 2：ORR as assessed by investigator [Time frame: Up to approximately 30 months after the first participant is enrolled]
- phase 2：PFS as assessed by IRC and investigator [Time frame: Up to approximately 30 months after the first participant is enrolled]
- Phase 3：PFS as assessed by invetigator [Time frame: Up to approximately 30 months after the first participant is enrolled]
- Phase 3：ORR as assessed by IRC and investigator [Time frame: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：OS [Time frame: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：DCR as assessed by IRC and investigator [Time frame: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：DoR as assessed by IRC and investigator [Time frame: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：TTR as assessed by IRC and investigator [Time frame: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：Frequency and severity of AEs (NCI CTCAE 5.0) [Time frame: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：PK parameters: The plasma concentration of glumetinib [Time frame: Up to approximately 30 months after the first participant is enrolled]
- phase 2/3：Biomarkers: c-MET expression and amplification levels, tumor-related gene mutations [Time frame: Up to approximately 30 months after the first participant is enrolled]
Eligibility criteria
Inclusion criteria
- 1\. Able to understand and voluntarily sign the written informed consent form (ICF); 2. Male or female subjects aged 18 to 75 years (inclusive). 3. Patients with NSCLC who have unresectable locally advanced or metastatic disease; 4. At least one measurable lesion, as defined by RECIST 1.1 criteria; 5. ECOG performance status of 0 or 1; 6. Expected survival ≥ 3 months; 7. Adequate function of major organs and bone marrow; 8. Women or man of childbearing potential must use highly effective contraception.
Exclusion criteria
- Prior treatment with an EGFR inhibitor or MET inhibitor;
- Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;
- Patients who have taken strong inducers or inhibitors of CYP3A4 within 2 weeks prior to the first dose of the study drug, or who cannot discontinue the use of strong CYP3A4 inducers and inhibitors during the study;
- Patients with a history of autoimmune diseases, a history of immunodeficiency, including positive for HIV, or other acquired or congenital immunodeficiency diseases, or a history of organ transplant;
- Presence of active infection (e.g., subjects are receiving anti-infection therapy);
- Severe or uncontrolled cardiovascular disorder requiring treatment;
- Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;
- Women who are pregnant or breastfeeding;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06908772 · SYH2065-003