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 (Jun 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 Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn, other discontinuation criterion is met, or study completion.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
Treatments studied
Targeted therapy
Chemotherapy
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.
Frequently asked questions
Is NCT05777278 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior MET inhibitor disqualifies patients from enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require MET?
Yes, MET exon 14 skipping mutation wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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