Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer
Part of paid clinical trials in Louisville, Kentucky.
- Sponsor
- Haihe Biopharma Co., Ltd.
- Study ID
- NCT04270591
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- C-Met Exon 14 Mutation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Glumetinib — DRUGThe investigational product will be orally administrated when fasting at dose level of 300mg QD
Study Details
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)
Key Dates
- Start date
- Jul 15, 2019
- Status verified
- Jul 2022
- Primary completion
- Oct 25, 2023
- Completion
- Dec 30, 2023
Study Design
- Enrollment
- 183 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: SCC244 300mgPhase Ib: SCC244 300mg, QD Phase II: SCC244 300mg, QD
Primary Outcome Measure
ORR [ Time Frame: through study completion, an average of 1 year ]
Central Contacts
- Shun LU, Doctor+86-21-22200000ext2153
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Norton Cancer Institute | Louisville | Kentucky | 40233 | Jaspreet Singh, Grewal |
| The Oncology Institute of Hope & Innovation | Louisville | Kentucky | 40233 | Stephen, Huang |