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NCT Number: NCT04566432

Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated NSCLC Patients

To evaluate the predictive value of ctDNA in response, relapse for patients treated with immune checkpoint inhibitors or targeted therapy for ALK, ROS1, MET ex14 skipping.

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Key information

Conditions

Lung Neoplasms Adenocarcinoma Adenocarcinoma of Lung Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer, Nonsmall Cell Lung Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Lung Cancer Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Chest Hospital

Shanghai, China

About this study

In the study, 250 advanced NSCLC patients will be recruited. All the patients will receive tissue biopsy and circultating tumor DNA (ctDNA) liquid biopsy before entry the study. Patients who have no actionable mutations in EGFR or ALK and receive ICIs treatment and patients who carry actionable ROS1 fusion, ALK fusion or MET exon 14 skipping mutation and receive TKI treatment according to guidelines will take liquid biopsy assay to monitor the mutation status. The study will be ended when over 70% of the patients had a progressive disease (PD) in their targeted lesion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of informed consent
  • Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively
  • No EGFR mutation in tissue and ctDNA
  • Received immune checkpoint inhibitors as the first line therapy
  • ECOG performance status 0-2 with expected more than 6 months of survival time
  • Willingness to comply with required protocols and give permission to use the data for clinical research and products development

Exclusion criteria

  • Patients have other primary cancers
  • Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders
  • Patients failed in either plasma or tissue sample QC

Treatment and study plan

observation

Other

observe the association of ctDNA with efficacy of treatment

Primary outcomes

  1. the evolution of ctDNA mutation profile during treatment

    Time frame: every 2-3 cycles of treatment upon physicians' request, ctDNA mutation analysis and clonal analysis (each cycle is 28 days)

    ctDNA mutation will be detected, PyClone based clonal analysis will be performed to analyze the clonal dominance

Secondary outcomes

  1. Resistant mechanisms of targeted therapy

    Time frame: At the time of disease progression (through study completion, an average of 1.5 years)

    Resistant mutations will be identified from ctDNA or tissue mutations

Sponsors and collaborators

Lead sponsor

Geneplus-Beijing Co. Ltd.

Industry

Collaborators

  • Shanghai Chest Hospital

Registry information

Official study title

Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients Treated With Immune Checkpoint Inhibitors (ICIs) or Targeted Therapy

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2020
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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