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

Sponsor
Hunan Province Tumor Hospital
Study ID
NCT04997382
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Aug 9, 2021
Start date
Aug 17, 2021
Status verified
May 2024
Primary completion
Jan 31, 2024
Completion
Jan 31, 2024

Study Design

Enrollment
112 participants (actual)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Patients with 3'ALK retained 5'ALK.
    Patients with 3'ALK retained 5'ALK who progressed from first line Alectinib were randomized to Arm A: Chemo+ICIs/Chemo+ICIs+BEV and Arm B: Chemo/Chemo+BEV.
  • Experimental: Part B: Patients with 3'ALK.
    Patients with 3'ALK who progressed from first line Alectinib were randomized to Arm C: Chemo+ICIs/Chemo+ICIs+BEV and Arm D: Chemo/Chemo+BEV.

Primary Outcome Measure

PFS [ Time Frame: From first dose until 28 days after the last dose, up to 24 months ]

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