A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Glumetinib (SCC244), a Selective MET Inhibitor in Patients With Advanced Non-Small Cell Lung Cancer Harboring MET-alterations
Haihe Biopharma Co., Ltd.
Summary
Indication:Patients with Advanced c-MET-positive Non-Small Cell Lung Cancer Phase Ib (China only): Approximately 90 patients Phase Ⅱ (globally): Approximately 78 evaluable patients; addition of at least 6 patients in Safety Run-in (US only)
Description
Phase Ib study population Approximately 90 patients with locally advanced or metastatic NSCLC (Stage IIIb, IIIc or IV) including pulmonary sarcomatoid carcinoma (PSC). All patients should carry at least one of the following MET alterations (confirmed by local or central laboratory): * Patients with METex14 skipping mutation who had previously treated by other MET inhibitor(s) * Patients with METex14 skipping mutation who had received 3 or more lines prior systemic therapies without MET inhibitor for the advanced NSCLC * Patients with MET amplification (GCN ≥ 4 or MET/CEP7 ratio ≥ 2) * Patien…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1. Provide informed consent voluntarily. 2. Male and female patients ≥ 18 years of age (or having reached the age of majority according to local laws and regulations, if the age is \> 18 years). 3. Histologically or cytologically confirmed diagnosis of NSCLC including PSC. 4. Patients with stage IIIb or IIIc NSCLC who are not candidates for definitive surgical resection or concurrent chemoradiation or patients with stage IV NSCLC (AJCC version 8). 5. For Phase Ib study, patients should carry at least one of the following MET alterations (by local or Sponsor-designated cent…
Interventions
- DrugGlumetinib
The investigational product will be orally administrated when fasting at dose level of 300mg QD
Locations (44)
- Norton Cancer InstituteLouisville, Kentucky
- The Oncology Institute of Hope & InnovationLouisville, Kentucky
- Anhui Province HospitalHefei, Anhui
- The Chest Hospital of Anhui ProvinceHefei, Anhui
- Beijing Cancer HospitalBeijing, Beijing Municipality
- Beijing Cancer HospitaBeijing, Beijing Municipality