NCT05198154

Brief Summary

This study aims to explore the correlation of circulating tumor DNA(ctDNA) and the risk of progression in patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

April 23, 2025

Status Verified

February 1, 2025

Enrollment Period

3.9 years

First QC Date

January 1, 2022

Last Update Submit

April 17, 2025

Conditions

Advanced Lung Non-Small Cell Carcinoma

Keywords

ctDNAadvanced lung cancerfirst-line immunotherapythe risk of progressionminimal residual disease (MRD)long-term benefit

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    The duration from study enrollment to disease progression or death, whichever occurs first.

    3 years

Secondary Outcomes (4)

  • The correlation of ctDNA and risk of progression

    3 years

  • Lead time

    3 years

  • Incidence of adverse events

    3 years

  • Overall survival (OS)

    3 years

Other Outcomes (3)

  • Objective response rate (ORR)

    3 years

  • Factors influencing ctDNA detection

    3 years

  • Differences between ctDNA MRD and other peripheral blood biomarkers.

    3 years

Study Arms (2)

Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-informed group)

The ctDNA detection will be performed using a tumor-informed analysis approach. This method requires the availability of tumor tissue samples or a fixed-panel next-generation sequencing (NGS) test.

Diagnostic Test: ctDNA detection

Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-agnostic group)

The ctDNA detection will be performed using a tumor-agnostic analysis. This method does not require tumor tissue samples or an NGS testing panel, or in cases where tissue samples are available but fail to meet quality control standards.

Diagnostic Test: ctDNA detection

Interventions

ctDNA detectionDIAGNOSTIC_TEST

High-depth sequencing method is used to detecting ctDNA.

Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-agnostic group)Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-informed group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Clinically confirmed advanced NSCLC patients with long-term benefit after first-line immunotherapy

You may qualify if:

  • Age ≥ 18 years old
  • Advanced non-small cell lung cancer (stage IIIB-IV), pathological types limited to squamous cell carcinoma or non-squamous cell carcinoma, driver gene mutations (EGFR/ALK/ROS1) were negative
  • General condition: ECOG score 0 or 1
  • First-line monotherapy or combination immunotherapy
  • The long-term benefit of immunotherapy was defined as PFS=12months
  • Tumor tissue samples can be obtained at the time of enrollment, and at least 5 \~ 10 sections can be generated, and the pathological report indicates that the overall tumor content is not less than 10% or NGS testing with a fixed-panel is available; or no tumor tissue is available.
  • At least one measurable lesion (except patients with CR after first-line treatment) can be evaluated according to RECIST1.1 standard.
  • Have self-awareness, be able to understand the research scheme and voluntarily participate in the study, and can sign the informed consent form
  • Have good compliance, be able to cooperate with the collection of specimens from each node and provide corresponding clinical information.

You may not qualify if:

  • Serious primary diseases of the heart, liver and kidney
  • Other malignant tumors within 3 years prior to diagnosis of NSCLC
  • Women in pregnancy and lactation
  • The active stage of human immunodeficiency virus (HIV) infection
  • Patients with active systemic infection, pneumonia, tuberculosis, pericarditis
  • Patients who cannot understand the content of the experiment and cannot cooperate and refuse to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Department，Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma cell free DNA

MeSH Terms

Conditions

Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Chunhong Hu, professor

CONTACT

+86 13508486908huchunh5829@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 1, 2022

First Posted

January 20, 2022

Study Start

January 24, 2022

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

April 23, 2025

Record last verified: 2025-02

Locations

CN(1)