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

NCT04997382 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-02-25

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Hunan Province Tumor Hospital

    lead OTHER

Principal Investigators

  • Yongchang Zhang, MD · Hunan Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-17
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997382 on ClinicalTrials.gov