OncoMatch/Clinical Trials/NCT05777278
Savolitinib Plus Docetaxel as 2L in EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC With MET Overexpression
Is NCT05777278 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Savolitinib and Docetaxel for non-small cell lung cancer.
Treatment: Savolitinib · Docetaxel — 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 Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn, other discontinuation criterion is met, or study completion.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Required: MET exon 14 skipping mutation wild-type
Required: MET overexpression (3+ in ≥50% of tumor cells)
Required: ROS1 wild-type
Disease stage
Metastatic disease required
locally advanced or metastatic EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC
Performance status
WHO OR ECOG 0–1
Prior therapy
Must have received: systemic therapy — first line
Has only received first line systemic treatment of non-targeted advanced NSCLC
Cannot have received: MET inhibitor (foretinib, crizotinib, cabozantinib, merestinib, onartuzumab, capmatinib, tepotinib)
Prior MET inhibitor therapy is not allowed. Prior exposure to HGF/MET inhibitors, e.g., foretinib, crizotinib, cabozantinib, merestinib, onartuzumab, capmatinib, tepotinib, etc.
Lab requirements
Blood counts
Haemoglobin ≥9 g/dL (no transfusion in past 2 weeks); ANC ≥1.5×10^9/L; Platelet count ≥100,000/μL (no transfusion in past 10 days)
Kidney function
serum creatinine <1.5 x ULN OR GFR ≥50 mL/min
Liver function
ALT and AST ≤2.5 x ULN with TBL ≤ ULN OR TBL >ULN to ≤1.5x ULN with ALT and AST ≤ ULN, ALP ≤ 2.5x ULN
Adequate haematological function defined as: Haemoglobin ≥9 g/dL (no transfusion in the past 2 weeks). Absolute neutrophil count ≥1.5×10^9/L. Platelet count ≥100,000/μL (no transfusion in the past 10 days). Adequate liver function defined as: ALT and AST ≤2.5 x ULN with TBL ≤ ULN OR TBL >ULN to ≤1.5x ULN with ALT and AST ≤ ULN, ALP ≤ 2.5x ULN. Adequate renal function defined as a serum creatinine <1.5 times the institutional ULN OR a glomerular filtration rate ≥50 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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