Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients

NCT06908772 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SYH2065-003
• Study Type: interventional
• Target: 390
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy and safety of glumetinib combined with osimertinib as the first-line treatment for locally advanced or metastatic NSCLC.

Conditions

Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression

Outcome Measures

Primary Outcomes (1)

• Phase 2：ORR as assessed by IRC

  Up to approximately 30 months after the first participant is enrolled

Secondary Outcomes (11)

• Phase 2：ORR as assessed by investigator

  Up to approximately 30 months after the first participant is enrolled

• phase 2：PFS as assessed by IRC and investigator

  Up to approximately 30 months after the first participant is enrolled

• Phase 3：PFS as assessed by invetigator

  Up to approximately 30 months after the first participant is enrolled

• Phase 3：ORR as assessed by IRC and investigator

  Up to approximately 30 months after the first participant is enrolled

• phase 2/3：OS

  Up to approximately 30 months after the first participant is enrolled

Study Arms (3)

Glumetinib（200 mg） + Osimertinib

EXPERIMENTAL

Group 1: Glumetinib 200 mg oral QD + Osimertinib 80 mg oral QD.

Drug: Glumetinib Tablets; Drug: Osimertinib Mesylate Tablets

Glumetinib（300mg） + Osimertinib

EXPERIMENTAL

Group 2: Glumetinib 300 mg oral QD + Osimertinib 80 mg oral QD;

Drug: Glumetinib Tablets; Drug: Osimertinib Mesylate Tablets

Osimertinib

EXPERIMENTAL

Group 3: Osimertinib 80 mg oral QD.

Drug: Osimertinib Mesylate Tablets; Drug: Glumetinib Tablets Placebo

Interventions

Glumetinib Tablets DRUG

An ATP competitive, highly selective MET receptor tyrosine kinase inhibitor

Glumetinib（200 mg） + Osimertinib; Glumetinib（300mg） + Osimertinib

Osimertinib Mesylate Tablets DRUG

3rd EGFR-TKI

Glumetinib（200 mg） + Osimertinib; Glumetinib（300mg） + Osimertinib; Osimertinib

Glumetinib Tablets Placebo DRUG

Placebo

Osimertinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

MeSH Terms

Conditions

Recurrence

Interventions

glumetinib; osimertinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, positive-controlled Phase Ⅱ/Ⅲ

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2030
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share