ALK Phosphorylation
Conditions
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.
Interventions
DRUGcrizotinib 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.
Sponsors
Harbin Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed