Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Crizotinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Yongchang Zhang, MD

Nong Yang, MD

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.

Real World Study of First Line Crizotinib for ALK Rearranged Non-squamous Non-small Cell Lung Cancer

A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ALK Rearranged Advanced Non Squamous Non-small Cell Lung Cancer

Hunan Province Tumor Hospital

Professor

Symptoms and General Pathology

Disease Progression

Bevacizumab

Immune Checkpoint Inhibitors

Pembrolizumab

Atezolizumab

Alectinib

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Patients who progressed from first line Alectinib will be treated with chemotherapy plus immune checkpoint inhibitors with or without Bevacizumab following the patients' preferences.

Patients who progressed from first line Alectinib will be treated with chemotherapy with or without Bevacizumab following the patients' preferences.

Immune Checkpoint Inhibitors, for pembrolizumab, 200mg ivgtt once,every 21 days; for Atezolizumab, 1200mg vgtt once,every 21 days.

Chemotherapy alone or Chemotherapy plus Immune Checkpoint Inhibitors with or without Bevacizumab

Chemotherapy alone or Chemotherapy with or without Bevacizumab

This study aimed to investigate the combination of chemotherapy and immunotherapy for patients with metastatic ALK fusion-positive non-small cell lung cancer (NSCLC) who had failed from first line Alectinib. Additionally, available biological samples such as blood and tumor tissues were collected to explore potential biomarkers, including but not limited to RNA-seq, whole-exome sequencing (WES), whole-genome sequencing (WGS), immunohistochemistry, and multiplex immunofluorescence.

1. The investigators collected data from patients with metastatic ALK fusion-positive non-small cell lung cancer (NSCLC) who received first-line Alectinib treatment between April 2017 and July 2021. Our analysis aimed to assess their clinical outcomes and explore the impact of 5' ALK on the treatment response to Alectinib.
2. For patients who experienced disease progression after August 2021, they were treated with a combination of chemotherapy and PD-1 monoclonal antibodies with/without Bevacizumab or chemotherapy alone with/without Bevacizumab was observed and recorded data on progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and overall survival (OS) for these patients.
3. The investigators collected pre-treatment biological samples for biomarker analysis, including FFPE samples for whole-genome sequencing (WGS), whole-exome sequencing (WES), RNA-seq, and multiplex fluorescence analysis. FFPE samples were also collected for PD-L1 testing. Additionally, pre-treatment blood samples were collected for cytokine analysis, as well as tumor mutational burden (TMB) and T-cell receptor (TCR) testing. The investigators aimed to evaluate the differences in these results between 3' ALK and 5' ALK.

Based on the treatment preferences of each patient, they received either chemotherapy alone or in combination with immune checkpoint inhibitors, as well as chemotherapy in combination with immune checkpoint inhibitors (ICI), either with or without bevacizumab.

Immunochemotherapy or Chemotherapy in ALK-rearranged 5'-ALK NSCLC

Chemotherapy Plus Immune Checkpoint Inhibitor With or Without Bevacizumab After Disease Progression With First-line Alectinib of Advanced ALK-rearranged Non-small Cell Lung Cancer With 5'-ALK

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Real World Study of First Line Crizotinib for ALK Rearranged Non-squamous Non-small Cell Lung Cancer	NCT03647111	Non-small Cell ...	Crizotinib	18 Years -	Hunan Province Tumor Hospital
Immunochemotherapy or Chemotherapy in ALK-rearranged 5'-ALK NSCLC	NCT04997382	Non-small Cell ...	Chemotherapy al... Chemotherapy al...	18 Years - 75 Years	Hunan Province Tumor Hospital
Real World Study of First Line Crizotinib for ALK Rearranged Non-squamous Non-small Cell Lung Cancer	NCT03647111	Non-small Cell ...	Crizotinib	18 Years -	Hunan Province Tumor Hospital

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