Completed

NCT Number: NCT05792644

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

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 .

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Key information

Conditions

ALK Phosphorylation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

crizotinib for rearrangement-negative, high phosphorylated ALK patients

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.

Primary outcomes

Clinical efficacy

Time frame: 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 outcomes

The progression-free survival

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2023
First posted: Mar 31, 2023
Registry last updated: Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.