drugset / Trial / NCT05777278
Savolitinib Plus Docetaxel as 2L in EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC With MET Overexpression
NaSingle-groupOpen-labelTreatment
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 Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn, other discontinuation criterion is met, or study completion.
Timeline
- Start
- 2023-07-26
- Primary completion
- 2027-08-31
- Completion
- 2027-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Savolitinib | Small molecule | 200 mg | Oral |
| Subject | Savolitinib | Small molecule | 300 mg | Oral |
| Background | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |