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

Not Applicable

Completed

• Conditions: ALK Phosphorylation
• Interventions: Drug: crizotinib for rearrangement-negative, high phosphorylated ALK patients

• Registration Number: NCT05792644
• Lead Sponsor: Harbin Medical University

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2022-05-01
• Study First Submitted: 2022-09-18
• Status Verified: 2023-03
• Study Completion: 2023-03-01
• Study First Submitted QC: 2023-03-19
• Last Update Submitted: 2023-03-19
• Study First Posted: 2023-03-31
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	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.

Primary Outcome Measures

Name	Time	Method
Clinical efficacy	SIx months	The clinical efficacy was evaluated according to the RECIST 1.1 guidelines\[5\], including PD, stable disease (SD), partial response (PR), and complete remission (CR), where the objective response rate (ORR) = (CR + PR) number of cases/total number of cases, and the disease control rate (DCR) = (CR + PR + SD) number/total number of cases.

Secondary Outcome Measures

Name	Time	Method
The progression-free survival	3 years	The progression-free survival (PFS) was defined as the time from the date of first treatment to any recurrence or last follow-up.

Trial Locations

Locations (1)

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China