Lung Cancer
Conditions
Interventions
Tepotinib plus EGFR TKI group:N/A
Other systemic therapy group:N/A
Sponsors
Ethics Committee of Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Written informed consent was voluntarily provided by the patient. 2.Age >=18 years, male or female. 3.Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with locally advanced or metastatic disease, not suitable for surgical resection or definitive concurrent chemoradiotherapy; the presence of EGFR-sensitizing mutations must have been confirmed prior to first-line treatment with an EGFR tyrosine kinase inhibitor (EGFR TKI). 4.Radiographically confirmed disease progression following first-line EGFR TKI therapy, and subsequent radiographic progression or lack of clinical benefit after second-line systemic treatment, with patients continuing to receive third-line and later systemic therapies. 5.Pathologically confirmed MET protein overexpression (immunohistochemistry [IHC] 2+), based on tumor samples obtained after first-line or second-line treatment. 6.At least one measurable lesion as defined by RECIST version 1.1. 7.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with an expected survival of >12 weeks. 8.Radiographic evidence of disease. 9.Ability to comply with study follow-up according to the study protocol.
Exclusion criteria
Exclusion criteria: 1.Presence of other actionable oncogenic driver alterations, such as ALK or ROS1 rearrangements, or other known targetable genomic alterations. 2.Presence of MET gene amplification or MET exon 14 skipping mutation (MET exon 14 skipping). 3.Prior exposure to c-MET–targeted therapies. 4.Failure to receive further systemic therapy after progression following first-line and second-line treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Duration of Response;Treatment-emergent adverse events (TEAEs); | — |
Countries
China
Contacts
Public ContactFeifei Teng
Cancer Hospital of Shandong First Medical University
Outcome results
None listed