RecruitingPhase 1Phase 2NCT05777278

Savolitinib Plus Docetaxel as 2L in EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC With MET Overexpression

A Prospective Study of Savolitinib Plus Docetaxel in Pretreated EGFR/ALK/ROS1/MET ex14m-wildtype Advanced NSCLC Patients With MET Overexpression (FirstMET)


Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Enrollment

29 participants

Start Date

Jul 26, 2023

Study Type

INTERVENTIONAL

Conditions

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 Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn, other discontinuation criterion is met, or study completion.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of savolitinib (a drug that blocks a protein called MET, which drives cancer growth) plus docetaxel (a standard chemotherapy) as a second-line treatment for people with advanced non-small cell lung cancer (NSCLC) that overexpresses MET but does not have the common driver mutations (EGFR, ALK, ROS1, or MET exon 14). **You may be eligible if...** - You are 18 or older with confirmed locally advanced or metastatic NSCLC - Your tumor does not have EGFR, ALK, ROS1 mutations, or MET exon 14 skipping mutations - Your tumor overexpresses MET (as confirmed by testing) - You have already received one prior first-line systemic treatment for advanced NSCLC - You have adequate organ function and performance status **You may NOT be eligible if...** - You have had more than one prior treatment for advanced disease - You have already received a MET inhibitor - You have active brain metastases or serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSavolitinib

Savolitinib (300mg or 200mg according to safety run-in recommendation, p.o., BID)

DRUGDocetaxel

Docetaxel (60 mg/m2, ivgtt, q3w)


Locations(1)

Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT05777278


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