Savolitinib Plus Docetaxel as 2L in EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC With MET Overexpression
NCT05777278 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2023-10-10
Summary
This is a prospective, pilot, single-arm, single-center study exploring the efficacy and safety of savolitinib plus docetaxel as second-line therapy in patients with MET overexpressed, EGFR/ALK/ROS1/MET ex14m-wildtype advanced NSCLC.
Participants will receive treatment of docetaxel (60 mg/m2, ivgtt, q3w) in combination with savolitinib (300mg or 200mg according to safety run-in recommendation, p.o., BID) after informed consent signed. Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn, other discontinuation criterion is met, or study completion.
Conditions
Interventions
- DRUG
-
Savolitinib
Savolitinib (300mg or 200mg according to safety run-in recommendation, p.o., BID)
- DRUG
-
Docetaxel (60 mg/m2, ivgtt, q3w)
Sponsors & Collaborators
-
The First Affiliated Hospital of Guangzhou Medical University
lead OTHER
Principal Investigators
-
Jianxing He, M.D · The First Affiliated Hospital of Guangzhou Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-26
- Primary Completion
- 2027-08-31
- Completion
- 2027-08-31
Countries
- China
Study Locations
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