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

NCT ID: NCT05792644

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2023-03-01

Brief Summary

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 .

Detailed 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.

Conditions

ALK Phosphorylation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

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.

Group Type: EXPERIMENTAL

crizotinib for rearrangement-negative, high phosphorylated ALK patients

Intervention Type: DRUG

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.

Interventions

crizotinib for rearrangement-negative, high phosphorylated ALK 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. Treatment with crizotinib continued until the patient experienced unacceptable toxicity, was pregnant, or started new cancer therapy.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xuemeng Li

Clinical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Countries

China

Other Identifiers

XLi

Identifier Type: -

Identifier Source: org_study_id