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This study is a single-arm, multicenter real-world clinical study designed to evaluate the safety and efficacy of Leucogen (a leukocyte-increasing agent) as a prophylactic treatment in patients with RET fusion-positive non-small cell lung cancer (NSCLC) who are being treated with Pralsetinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pralsetinib Combined with Leucogen | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pralsetinib | Drug | Pralsetinib 400mg orally once daily on an empty stomach (4 weeks as a cycle, until disease progression, death, or intolerance) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The grade and incidence of leukopenia and neutropenia at 1 month after the first administration of Pralsetinib | Metric/method of measurement:Blood samples are collected at specified time points, and indicator values are obtained through routine blood tests. The results are graded according to the CTCAE 5.0 criteria, and finally the incidence of each grade is calculated. At 1 month after the first administration of Pralsetinib. Assessed | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The grade and incidence of Leukopenia and neutropenia at 2 months and 3 months after the first administration of Pralsetinib | Metric/method of measurement:Blood samples are collected at specified time points, and indicator values are obtained through routine blood tests. The results are graded according to the CTCAE 5.0 criteria, and finally the incidence of each grade is calculated. At 2 months and 3 months after the first administration of Pralsetinib. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jialei Wang, MD | Contact | 021-64175590 | hatitunqiao@163.com | |
| Hui Yu, MD | Contact | 021-64175590 | hatitunqiao@163.com |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000655704 | pralsetinib |
| C001176 | Leyk |
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|
| Leucogen | Drug | Leucogen 20mg orally three times daily for continuous prophylactic treatment for 3 months |
|
| up to 24 months |
| Incidence of Grade 3 Treatment-Related Adverse Events (TRAE), and Incidence of Dose Interruption/Reduction/Disc continuation | The incidence of Grade 3 Treatment-Related Adverse Events (TRAE) refers to the probability of recording treatment-related adverse events that meet the Grade 3 criteria of CTCAE Version 5.0 in subjects from the first administration to 28 days after the last administration, while the incidence of dose interruption/reduction/discontinuation refers to the probability of recording corresponding events caused by drug toxicity. | up to 24 months |
| Time to Treatment Failure (TTF) | Time from the start of treatment to the first occurrence of a treatment failure event | up to 24 months |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 Items (EORTC QLQ-LC30) | EORTC QLQ-LC13 has 13 questions and scores range from 0-100 after a linear transformation. Negative change from baseline scores indicates less symptom severity, and thus improvement on health status. | Up to 24 months |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30) | QLQ-C30 has 30 questions and scores range from 0-100 after a linear transformation. Positive change from baseline scores on the GHS/QoL and functioning scales indicate improvement on health status/function, and negative change scores on symptom scales/items represent less symptom severity/improvement on symptom status. | up to 24 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |