Spots Global Cancer Trial Database for Immunochemotherapy or Chemotherapy in ALK-rearranged 5'-ALK NSCLC

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Trial Identification

Brief Title: Immunochemotherapy or Chemotherapy in ALK-rearranged 5'-ALK NSCLC

Official Title: 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 ID: NCT04997382

Conditions

Non-small Cell Lung Cancer

Interventions

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

Chemotherapy alone or Chemotherapy with or without Bevacizumab

Study Description

Brief Summary: 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.

Detailed Description: 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.