Therapeutic Effect of Crizotinib for Rearrangement-negative, High Phosphorylated ALK Patients

Harbin Medical University

Status: Completed

Conditions: ALK Phosphorylation

Treatments: Drug: crizotinib for rearrangement-negative, high phosphorylated ALK patients

Study type: Interventional

Funder types: Other

Identifiers

NCT05792644

XLi

Details and patient eligibility

About

Patients with histologically or cytologically confirmed stage IIIB or IV ALK-negative non-small-cell lung cancer (NSCLC) participated in this study following the failure of initial treatments. The ALK phosphorylation expression was detected in histologic samples of patients. patients with positive ALK phosphorylation expression were treated with crizotinib .

Full description

Some patients with histologically or cytologically confirmed stage IIIB or IV ALK-negative non-small-cell lung cancer (NSCLC) participated in this study following the failure of initial treatments. The ALK phosphorylation expression was detected in histologic samples of patients. patients with positive ALK phosphorylation expression were treated with crizotinib 250 mg/day orally. A treatment cycle was defined as 30 days of once-daily crizotinib treatment.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 years and 80 years
2. Histologically or cytologically confirmed stage IIIB or IV ALK-negative NSCLC by NGS
3. Disease staging determined according to the International Association for the Study of Lung Cancer 8th edition TNM staging system
4. All measurable Response Evaluation Criteria in Solid Tumors (RECIST) target lesions
5. Treatment failure at the end of the most recent treatment episode
6. World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status 0-2
7. Consent of patients for participation in this study
8. Complete clinical data
9. High ALK phosphorylation level

Exclusion criteria

1. Patients with cognitive impairment, severe psychiatric diseases, or other disorders likely to impact informed consent
2. Patients with uncontrolled systemic disease
3. Patients with other malignant tumors

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Experimental

Experimental group

Description:

Patients with positive ALK phosphorylation expression were treated with crizotinib 250 mg/day orally. A treatment cycle was defined as 30 days of once-daily crizotinib treatment. Treatment with crizotinib continued until the patient experienced unacceptable toxicity, was pregnant, or started new cancer therapy.

Treatment:

Drug: crizotinib for rearrangement-negative, high phosphorylated ALK patients