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

No results posted yet for this study

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 Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn, other discontinuation criterion is met, or study completion.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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05777278 on ClinicalTrials.gov