OncoMatch/Clinical Trials/NCT04237805
A Phase I/II Clinical Study of SAF-189s in Non-small Cell Lung Cancer (NSCLC) Patients
Is NCT04237805 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies SAF-189s for advanced cancer.
Treatment: SAF-189s — The study comprises two phases: phase I dose escalation (including PK run-in period and treatment period) and phase II study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK fusion
ALK-positive
Required: ROS1 fusion
ROS1 positive
Disease stage
Required: Stage IIIB, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: ALK inhibitor
Exception: Phase II: patients may have received no more than one ALK inhibitor for progression or intolerance
Patients who had not previously received or had received only one ALK/ROS1 inhibitor for disease progression or intolerance, and who had no more than 3 previous treatment lines overall
Cannot have received: ROS1 inhibitor
Exception: Phase II: patients may have received no more than one ROS1 inhibitor for progression or intolerance; cohort 2: only crizotinib allowed as prior ROS1 inhibitor
Patients who had not previously received or had received only one ALK/ROS1 inhibitor for disease progression or intolerance, and who had no more than 3 previous treatment lines overall; cohort 2: patients ... who had previously only received crizotinib as a ROS1 inhibitor for disease progression or intolerance and had no more than 3 overall previous treatment lines; The second cohort received ROS1 inhibitors other than crizotinib [excluded]
Cannot have received: systemic therapy
Exception: cohort 1: no prior systemic therapy or only one line of non-ROS1-inhibitor treatment
cohort1：ROS1-positive ... with no prior systemic therapy or only one line of non-ROS1-inhibitor treatment
Cannot have received: chemotherapy
Has had prior chemotherapy, anti-cancer treatment with biological drugs, or other investigational agents within 28 days or received TKI or targeted therapies within 14 days prior to enrollment
Cannot have received: biological therapy
Has had prior chemotherapy, anti-cancer treatment with biological drugs, or other investigational agents within 28 days or received TKI or targeted therapies within 14 days prior to enrollment
Cannot have received: TKI or targeted therapy
Has had prior chemotherapy, anti-cancer treatment with biological drugs, or other investigational agents within 28 days or received TKI or targeted therapies within 14 days prior to enrollment
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Hemoglobin ≥ 90 g/L; Platelets (PLT) ≥ 100 × 10^9/L
Kidney function
Creatinine clearance (CrCL) ≥ 50 mL/min (calculated by Cockcroft-Gault equation)
Liver function
Serum total bilirubin ≤ 1.5 × ULN (if the patient has Gilbert's syndrome, ≤ 3 × ULN and direct bilirubin ≤ 1.5 × ULN); AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for patient with liver metastases)
Cardiac function
Corrected QT interval using Fridericia formula > 450 msec for male patients and > 470 msec for female patients [excluded]; Impairment of cardiac function or clinically significant heart disease, including NYHA grade ≥ 3 congestive heart failure, arrhythmias, conduction abnormalities requiring treatment, cardiomyopathy, or uncontrolled hypertension [excluded]
Patient with appropriate organ function as documented by: ... (see above for details); Corrected QT interval using Fridericia formula > 450 msec for male patients and > 470 msec for female patients [excluded]; Impairment of cardiac function or clinically significant heart disease, including NYHA grade ≥ 3 congestive heart failure, arrhythmias, conduction abnormalities requiring treatment, cardiomyopathy, or uncontrolled hypertension
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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