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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.

Phase 1/2RecruitingThe First Affiliated Hospital of Guangzhou Medical UniversityNCT05777278Data as of Jun 2026Location: China

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 Treatment will continue until either objective disease progression, unacceptable toxicity occurs, consent is withdrawn, other discontinuation criterion is met, or study completion.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Savolitinib

Chemotherapy

Docetaxel

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

Max 1 prior line
Min 1 prior line

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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