NCT04997382

Chemotherapy Combined with ICIs in First-line Alectinib Failed Patients with ALK-rearranged NSCLC

Chemotherapy Combined with Immune Checkpoint Inhibitors in Patients with ALK-rearranged Non-small Cell Lung Cancer (NSCLC) Who Have Progressed After First-line Alectinib: a Proof-of-concept, Phase 2 Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Hunan Province Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Chemotherapy alone or Chemotherapy plus Immune Checkpoint Inhibitors with or without Bevacizumab	Immune Checkpoint Inhibitors, for pembrolizumab, 200mg ivgtt once,every 21 days; for Atezolizumab, 1200mg vgtt once,every 21 days.
DRUG	Chemotherapy alone or Chemotherapy with or without Bevacizumab	Bevacizumab, 15mg/kg，every 21 day

Timeline

• Start date: 2021-08-17
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2021-08-09
• Last updated: 2025-02-25

Locations

1 site across 1 country: China