OncoMatch/Clinical Trials/NCT06436885
An Exploratory Study of Efficacy and Safety of Iruplinalkib Tablets in Patients With ROS1 Positive Non-small Cell Lung Cancer
Is NCT06436885 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Iruplinalkib tablets for non-small cell lung cancer.
Treatment: Iruplinalkib tablets — This is a single-arm, open, multicenter exploratory clinical trial to observe and evaluate the efficacy and safety of Iruplinalkib Tablets in patients with ROS1 positive non-small cell lung cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ROS1 fusion
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5×10^9/L; Platelet ≥100×10^9/L; Hemoglobin ≥90 g/L; Serum albumin ≥30 g/L; INR ≤1.5×ULN (not receiving anticoagulation therapy)
Kidney function
Serum creatinine ≤1.5×ULN
Liver function
Serum total bilirubin ≤1.5×ULN; ALT and AST≤ 2.5 x ULN; if liver metastasis exists, ALT and AST≤5ULN; AKP≤ 2.5×ULN
Cardiac function
QTc>450ms (male); QTc>470ms (Female); NYHA2 or higher heart failure; unstable angina; myocardial infarction within 1 year; clinically significant arrhythmia
The function of vital organs meets the following requirements... (see above for details); Have clinical symptoms or diseases of heart that are not well controlled, such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc>450ms (male); QTc>470ms (Female)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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