Actively Recruiting
Savolitinib Plus Docetaxel as 2L in EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC With MET Overexpression
Led by The First Affiliated Hospital of Guangzhou Medical University · Updated on 2023-10-10
29
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn, other discontinuation criterion is met, or study completion.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
Official Title
Savolitinib Plus Docetaxel as 2L in EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC With MET Overexpression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent and comply with study requirements
- Age 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC without EGFR, ALK, ROS1, or MET exon 14 mutations
- Have received only first-line non-targeted systemic treatment for advanced NSCLC
- MET overexpression confirmed by immunohistochemistry (IHC), 3+ in at least 50% of tumor cells
- ECOG performance status 0 or 1 without deterioration in the last 2 weeks and life expectancy of at least 12 weeks
- At least one measurable lesion of at least 10 mm (or lymph node short axis ≥15 mm) suitable for repeated measurements
- Adequate blood counts: hemoglobin ≥9 g/dL, neutrophils ≥1.5 ×10^9/L, platelets ≥100,000/μL
- Adequate liver function with ALT and AST ≤2.5 times upper limit of normal (ULN) and total bilirubin ≤ ULN, or total bilirubin up to 1.5 × ULN with normal ALT, AST, and alkaline phosphatase ≤2.5 × ULN
- Adequate kidney function with serum creatinine <1.5 × ULN or glomerular filtration rate ≥50 mL/min
- Adequate coagulation parameters (INR <1.5 and aPTT <1.5 × ULN unless on therapeutic anticoagulation)
- Stable tumor thrombus or deep vein thrombosis on low molecular weight heparin for at least 2 weeks
- Able to swallow and retain oral medications
- Willing and able to follow study and follow-up procedures
- For females of childbearing potential, willing to use effective contraception and not breastfeeding, with negative pregnancy test or evidence of non-childbearing status
- For males with female partners of childbearing potential, willing to use barrier contraception and avoid sperm donation during and for 6 months after treatment
You will not qualify if you...
- Active gastrointestinal disease or conditions affecting oral drug absorption or metabolism
- Recent or current serious heart conditions within 6 months such as unstable angina, heart failure (NYHA grade ≥2), heart attack, stroke, or transient ischemic attack
- Uncontrolled high blood pressure (≥150/95 mmHg)
- Prolonged QT interval on ECG or risk factors for QT prolongation
- Significant ECG abnormalities such as complete left bundle branch block or high-degree heart block
- Serious medical conditions impairing ability to receive treatment
- Recent wide field radiotherapy within 28 days or limited field radiation within 7 days prior to treatment
- Recent major surgery within 28 days or minor surgery within 7 days before treatment
- Severe or uncontrolled systemic diseases including renal transplant or active bleeding disorders
- Active hepatitis B or C infection unless specific monitoring and treatment criteria are met
- Other active cancers or history of invasive cancer within 5 years, with some exceptions
- Unresolved toxicities from prior therapy greater than grade 1 except hair loss
- Symptomatic or unstable brain metastases or leptomeningeal metastases
- History of interstitial lung disease or drug-induced lung disease requiring steroids
- Known serious infections including HIV
- History of serious liver disease or cirrhosis and related conditions
- Known contraindications or allergies to docetaxel or savolitinib
- Pregnant or breastfeeding women
- History of Stevens Johnson syndrome or severe skin toxicity
- Prior treatment with HGF/MET inhibitors
- Use of medications or herbal supplements that strongly induce or inhibit CYP enzymes within 2 weeks prior to study drug
- Participation in other interventional clinical trials recently or concurrently
- Investigator judgment of inability to comply or other reasons preventing participation
- Previous enrollment in this study
- Lack of legal capacity to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
J
Jianxing He, M.D
CONTACT
W
Wenhua Liang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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