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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.

Early Phase 1RecruitingHenan Cancer HospitalNCT06436885Data as of May 2026

Treatment: Iruplinalkib tabletsThis 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.

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Extracted 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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