OncoMatch/Clinical Trials/NCT06031558
Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC
Is NCT06031558 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies SY-5007 for non-small cell lung cancer.
Treatment: SY-5007 — This is a phase III, open-label, single-arm, multicenter study designed to evaluate the anti-tumor activity and safety of SY-5007 administered orally to participants with locally advanced or metastatic RET-positive NSCLC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: RET fusion
RET fusion positive by local laboratory testing or central laboratory, using a next-generation sequencing (NGS)-based assay to confirm RET fusion positive
Required: EGFR major driver genetic alteration
Patients carried known major driver genetic alterations other than RET. e.g. EGFR, MET, ALK, ROS1, NTRK, BRAF V600, KRAS G12C, etc.
Required: MET major driver genetic alteration
Patients carried known major driver genetic alterations other than RET. e.g. EGFR, MET, ALK, ROS1, NTRK, BRAF V600, KRAS G12C, etc.
Required: ALK fusion
Patients carried known major driver genetic alterations other than RET. e.g. EGFR, MET, ALK, ROS1, NTRK, BRAF V600, KRAS G12C, etc.
Required: ROS1 fusion
Patients carried known major driver genetic alterations other than RET. e.g. EGFR, MET, ALK, ROS1, NTRK, BRAF V600, KRAS G12C, etc.
Required: NTRK1 fusion
Patients carried known major driver genetic alterations other than RET. e.g. EGFR, MET, ALK, ROS1, NTRK, BRAF V600, KRAS G12C, etc.
Required: NTRK2 fusion
Patients carried known major driver genetic alterations other than RET. e.g. EGFR, MET, ALK, ROS1, NTRK, BRAF V600, KRAS G12C, etc.
Required: NTRK3 fusion
Patients carried known major driver genetic alterations other than RET. e.g. EGFR, MET, ALK, ROS1, NTRK, BRAF V600, KRAS G12C, etc.
Required: BRAF V600
Patients carried known major driver genetic alterations other than RET. e.g. EGFR, MET, ALK, ROS1, NTRK, BRAF V600, KRAS G12C, etc.
Required: KRAS G12C
Patients carried known major driver genetic alterations other than RET. e.g. EGFR, MET, ALK, ROS1, NTRK, BRAF V600, KRAS G12C, etc.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic antitumor therapy
Exception: adjuvant therapy completed ≥ 6 months prior to the first dose; radical radiotherapy completed ≥ 6 months prior to the first dose
No prior systemic antitumor therapy for locally advanced or metastatic NSCLC (Note: enrollment is permitted in the following 2 situations: 1) received only adjuvant therapy and the end of treatment was ≥ 6 months prior to the first dose; 2) received only radical radiotherapy and the end of treatment was ≥ 6 months prior to the first dose).
Cannot have received: palliative radiotherapy
Palliative radiotherapy within 1 week prior to the first dose, or any lung radiotherapy with more than 30 Gy of radiation within 6 months prior to the first dose.
Cannot have received: major surgical procedure
Exception: central venous catheterization, tumor puncture biopsy, and gastric tube placement allowed
Major surgical procedure (except central venous catheterization, tumor puncture biopsy, and gastric tube placement) or significant trauma within 4 weeks prior to the first dose.
Lab requirements
Blood counts
absolute neutrophil count (ANC) ≥ 1.5 x 10^9 /L, platelet (PLT) count ≥ 75 x 10^9 /L, and hemoglobin (Hb) ≥ 90 g/L; no blood products, hematopoietic cell growth factors or other blood medications for at least 7 days prior to the first dose
Kidney function
creatinine clearance (Ccr) ≥ 50 mL/min
Liver function
total bilirubin (TBIL) ≤ 1.5 times upper limit of normal (ULN) and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN in the absence of liver metastases; in the presence of liver metastases, both AST and ALT ≤ 5.0 times ULN and TBIL ≤ 3 times ULN
Cardiac function
QTcF ≤ 470 msec (females) or ≤ 450 msec (males) using Fridericia formula; left ventricular ejection fraction (LVEF) ≥ 45%; no myocardial infarction or unstable angina pectoris or clinically significant uncontrolled arrhythmia within 6 months; no class III or IV NYHA congestive heart failure; poorly controlled hypertension (systolic >150 mmHg or diastolic >100 mmHg), history of unstable hypertension, or history of poor compliance with antihypertensive therapy
Patients must have adequate organ function as defined in the below: Bone marrow function: patients must not have received any blood products, hematopoietic cell growth factors or other blood medications for at least 7 days prior to the first dose, and have a blood count: absolute neutrophil count (ANC) ≥ 1.5 x 10^9 /L, platelet (PLT) count ≥ 75 x 10^9 /L, and hemoglobin (Hb) ≥ 90 g/L; Liver function: total bilirubin (TBIL) ≤ 1.5 times upper limit of normal (ULN) and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN in the absence of liver metastases; in the presence of liver metastases, both AST and ALT ≤ 5.0 times ULN and TBIL ≤ 3 times ULN; Renal function: creatinine clearance (Ccr) ≥ 50 mL/min. Coagulation function: prothrombin time (PT) or International Normalized Ratio (INR) ≤ 1.5 times ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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