CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 112 enrolled
Drug / intervention
Chemotherapy alone or Chemotherapy plus Immune Checkpoint Inhibitors with or without Bevacizumab +1 moredrug
Likely dose
Chemotherapy alone or Chemotherapy plus Immune Checkpoint Inhibitors with or without Bevacizumab 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04997382
NCT04997382Phase 2Completed

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

Hunan Province Tumor Hospital·interventional·Posted Aug 9, 2021·Updated Feb 25, 2025

In Brief

A Phase 2 clinical trial evaluating Chemotherapy alone or Chemotherapy plus Immune Checkpoint Inhibitors with or without Bevacizumab and Chemotherapy alone or Chemotherapy with or without Bevacizumab for Non-small Cell Lung Cancer. Completed, enrolled 112 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedAug 9, 2021
Enrollment StartAug 17, 2021
Primary CompletionJan 31, 2024
TodayJul 1, 2026
Enrollment to primary: 2.5 yearsPosted 4.9 years ago

Interventions

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

Immune Checkpoint Inhibitors, for pembrolizumab, 200mg ivgtt once,every 21 days; for Atezolizumab, 1200mg vgtt once,every 21 days.

Chemotherapy alone or Chemotherapy with or without Bevacizumabdrug

Bevacizumab, 15mg/kg,every 21 day