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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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ALK Phosphorylation

Intervention / Treatment
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* Drug: crizotinib for rearrangement-negative, high phosphorylated ALK patients


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy | 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. | SIx months | 

Secondary Outcome Measures

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