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This study aims to explore the efficacy and safety of Crizotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world.
According to the study of P11014 and P1029, Crizotinib is a first-line therapy for advanced non squamous non small cell lung cancer with positive ALK rearrangement.This study aims to explore the efficacy and safety of clozotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world. Among them, ALK positive was based on NGS test results, exploring the new drug resistance mechanism of ALK under clozotinib treatment mode and consistency between plasma and tissue detection driving genes, and finally assessing the role of plasma dynamic detection driving gene mutation spectrum in predicting disease progression risk. A retrospective study of 120 patients with advanced NSCLC using clozotinib ALK positive mutation was conducted to observe the efficacy and safety of clozotinib regimen in the real world.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohorts 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizotinib | Drug | Crizotinib 250mg po bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression free survival | Approximately 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival | Approximately 1 years |
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Inclusion Criteria:
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the patients who diagnosed ALK positive mutation in advanced non squamous non small cell lung cancer treated by Crizotinib.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongchang Zhang, MD | Contact | +8613873123436 | +8613873123436 | zhangyongchang@csu.edu.cn |
| Nong Yang, MD | Contact | +8613873123436 | +8613873123436 | yangnong0217@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongchang Zhang, MD | Hunan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35405360 | Derived | Zhou Y, Song L, Xu Q, Zeng L, Jiang W, Yang N, Zhang Y. Investigation on the survival implications of PD-L1 expression status in ALK- rearranged advanced non-small cell lung cancer treated with first-line crizotinib. Lung Cancer. 2022 May;167:58-64. doi: 10.1016/j.lungcan.2022.04.002. Epub 2022 Apr 6. | |
| 32112982 | Derived |
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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 |
|---|---|
| D000077547 | Crizotinib |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
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tissue sample and plasma DNA
| Zhang Y, Zeng L, Zhou C, Li Y, Wu L, Xia C, Jiang W, Hu Y, Liao D, Xiao L, Liu L, Yang H, Xiong Y, Guan R, Lizaso A, Mansfield AS, Yang N. Detection of Nonreciprocal/Reciprocal ALK Translocation as Poor Predictive Marker in Patients With First-Line Crizotinib-Treated ALK-Rearranged NSCLC. J Thorac Oncol. 2020 Jun;15(6):1027-1036. doi: 10.1016/j.jtho.2020.02.007. Epub 2020 Feb 27. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011725 |
| Pyridines |