Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or OverexpressionPhase 2/3NCT06908772
Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients
A Phase 2/3 study testing Glumetinib Tablets and Osimertinib Mesylate Tablets in people with Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression, run by Shanghai JMT-Bio Inc..
Trial summary
To evaluate the efficacy and safety of glumetinib combined with osimertinib as the first-line treatment for locally advanced or metastatic NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression
- What is being tested?
- Glumetinib Tablets and Osimertinib Mesylate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 31 Jan 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
To evaluate the efficacy and safety of glumetinib combined with osimertinib as the first-line treatment for locally advanced or metastatic NSCLC.
Read the 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.
- Being tested
- Glumetinib Tablets, Osimertinib Mesylate Tablets, Glumetinib Tablets Placebo
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glumetinib TabletsDrug
An ATP competitive, highly selective MET receptor tyrosine kinase inhibitor
Osimertinib Mesylate TabletsDrug
3rd EGFR-TKI
Glumetinib Tablets PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Glumetinib（200 mg） + Osimertinib | Experimental | Group 1: Glumetinib 200 mg oral QD + Osimertinib 80 mg oral QD. Receives: Drug: Glumetinib Tablets; Drug: Osimertinib Mesylate Tablets |
| Glumetinib（300mg） + Osimertinib | Experimental | Group 2: Glumetinib 300 mg oral QD + Osimertinib 80 mg oral QD; Receives: Drug: Glumetinib Tablets; Drug: Osimertinib Mesylate Tablets |
| Osimertinib | Experimental | Group 3: Osimertinib 80 mg oral QD. Receives: Drug: Osimertinib Mesylate Tablets; Drug: Glumetinib Tablets Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2：ORR as assessed by IRC
Measured: Up to approximately 30 months after the first participant is enrolled
Secondary outcomes (11)
Phase 2：ORR as assessed by investigator
Measured: Up to approximately 30 months after the first participant is enrolled
phase 2：PFS as assessed by IRC and investigator
Measured: Up to approximately 30 months after the first participant is enrolled
Phase 3：PFS as assessed by invetigator
Measured: Up to approximately 30 months after the first participant is enrolled
Phase 3：ORR as assessed by IRC and investigator
Measured: Up to approximately 30 months after the first participant is enrolled
phase 2/3：OS
Measured: Up to approximately 30 months after the first participant is enrolled
phase 2/3：DCR as assessed by IRC and investigator
Measured: Up to approximately 30 months after the first participant is enrolled
phase 2/3：DoR as assessed by IRC and investigator
Measured: Up to approximately 30 months after the first participant is enrolled
phase 2/3：TTR as assessed by IRC and investigator
Measured: Up to approximately 30 months after the first participant is enrolled
phase 2/3：Frequency and severity of AEs (NCI CTCAE 5.0)
Measured: Up to approximately 30 months after the first participant is enrolled
phase 2/3：PK parameters: The plasma concentration of glumetinib
Measured: 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
Measured: Up to approximately 30 months after the first participant is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or OverexpressionStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, positive-controlled Phase Ⅱ/Ⅲ
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908772
- Sponsor's protocol ID
- SYH2065-003
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06908772
- Acronym / sponsor ID
- SYH2065-003
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, positive-controlled Phase Ⅱ/Ⅲ
| Arm | Type | Receives |
|---|---|---|
| Glumetinib（200 mg） + Osimertinib | Experimental | Drug: Glumetinib Tablets, Drug: Osimertinib Mesylate TabletsGroup 1: Glumetinib 200 mg oral QD + Osimertinib 80 mg oral QD. |
| Glumetinib（300mg） + Osimertinib | Experimental | Drug: Glumetinib Tablets, Drug: Osimertinib Mesylate TabletsGroup 2: Glumetinib 300 mg oral QD + Osimertinib 80 mg oral QD; |
| Osimertinib | Experimental | Drug: Osimertinib Mesylate Tablets, Drug: Glumetinib Tablets PlaceboGroup 3: Osimertinib 80 mg oral QD. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glumetinib TabletsAn ATP competitive, highly selective MET receptor tyrosine kinase inhibitor | Drug | Glumetinib（200 mg） + Osimertinib, Glumetinib（300mg） + Osimertinib |
| Osimertinib Mesylate Tablets3rd EGFR-TKI | Drug | Glumetinib（200 mg） + Osimertinib, Glumetinib（300mg） + Osimertinib, Osimertinib |
| Glumetinib Tablets PlaceboPlacebo | Drug | Osimertinib |
Primary outcome
Phase 2：ORR as assessed by IRC
Time frame: Up to approximately 30 months after the first participant is enrolled
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Glumetinib Tablets and Osimertinib Mesylate Tablets in people with Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression, run by Shanghai JMT-Bio Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2：ORR as assessed by IRC (time frame: Up to approximately 30 months after the first participant is enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.