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

Sponsor

Harbin Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05792644

Collaborator

(none)

Enrollment

Location

Arm

61.9

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
ALK Phosphorylation	Drug: crizotinib for rearrangement-negative, high phosphorylated ALK patients	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model 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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Therapeutic Effect of Crizotinib in Patients With ALK-rearrangement-negative But High Expression of ALK Phosphorylation

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

May 1, 2022

Actual Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.

Arm

Intervention/Treatment

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	China	150000

Sponsors and Collaborators

Harbin Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xuemeng Li, Clinical Doctor, Harbin Medical University

ClinicalTrials.gov Identifier:

NCT05792644

Other Study ID Numbers:

First Posted:

Mar 31, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Crizotinib

Study Results

No Results Posted as of Mar 31, 2023