Ignite Creation Date:
2024-05-06 @ 4:28 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04997382
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2021-07-31
Brief Title:
Immunochemotherapy or Chemotherapy in ALK-rearranged 5-ALK NSCLC
Sponsor:
Hunan Province Tumor Hospital
Organization:
Hunan Province Tumor Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLASSIC5
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 withwithout Bevacizumab or chemotherapy alone withwithout 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
2 For patients who experienced disease progression after August 2021 they were treated with a combination of chemotherapy and PD-1 monoclonal antibodies withwithout Bevacizumab or chemotherapy alone withwithout 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None