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

Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Study ID
NCT05777278
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Savolitinib — DRUG
    Savolitinib (300mg or 200mg according to safety run-in recommendation, p.o., BID)
  • Docetaxel — DRUG
    Docetaxel (60 mg/m2, ivgtt, q3w)

Study Details

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 Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn, other discontinuation criterion is met, or study completion.

Key Dates

Start date
Jul 26, 2023
Status verified
Oct 2023
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Savolitinib Plus Docetaxel
    Single Arm

Primary Outcome Measure

ORR (Objective Response Rate) [ Time Frame: The analysis will occur at 12 weeks after last patient in. ]

Central Contacts

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