Clinical trial · Interventional

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

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

NCT06908772CI-TRIAL-00088048not yet recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Recurrent or Metastatic NSCLC Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression	—	UNRESOLVED	—

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Glumetinib Tablets	Drug	—	UNRESOLVED
Glumetinib Tablets Placebo	Drug	—	UNRESOLVED
Osimertinib Mesylate Tablets	Drug	Osimertinib	ALIAS

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
Glumetinib（200 mg） + Osimertinib
description
Group 1: Glumetinib 200 mg oral QD + Osimertinib 80 mg oral QD.
interventionNames
1. Drug: Glumetinib Tablets
2. Drug: Osimertinib Mesylate Tablets
type
EXPERIMENTAL
label
Glumetinib（300mg） + Osimertinib
description
Group 2: Glumetinib 300 mg oral QD + Osimertinib 80 mg oral QD;
interventionNames
1. Drug: Glumetinib Tablets
2. Drug: Osimertinib Mesylate Tablets
type
EXPERIMENTAL
label
Osimertinib

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

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:

1. Prior treatment with an EGFR inhibitor or MET inhibitor;
2. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;
3. 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;
4. 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;
5. Presence of active infection (e.g., subjects are receiving anti-infection therapy);
6. Severe or uncontrolled cardiovascular disorder requiring treatment;
7. Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;
8. Women who are pregnant or breastfeeding;

References

Publications (0)

Data not yet available

No reference posted for this study.