NCT05822284

Brief Summary

The goal of this observational study is to explore whether ctDNA-MRD dynamic monitoring can more effectively predict the therapeutic effect of induction chemoimmunotherapy followed by surgery or non-surgical treatment for stage IIIB-C driver-negative NSCLC in the MDT model, so as to accurately guide clinical diagnosis and treatment.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
33mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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

Study Progress54%
Apr 2023Mar 2029

Study Start

First participant enrolled

April 1, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

5.9 years

First QC Date

April 4, 2023

Last Update Submit

April 18, 2023

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

  • Predicting Progression Free Survival

    Ability of dynamic ctDNA-MRD assessment to predict progression-free survival (PFS) in stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy followed by surgery or non-surgical therapy

    up to 5 years

  • Predicting pathologic complete response

    Ability of dynamic ctDNA-MRD assessment to predict pathologic complete response (pCR) in stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy followed by surgery

    Up to 1 year

  • Predicting Overall Survival

    Ability of dynamic ctDNA-MRD assessment to predict overall survival (OS) in stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy followed by surgery or non-surgical therapy

    up to 5 years

Secondary Outcomes (6)

  • Objective response rate(ORR)

    Up to 1 year

  • Adverse events (AEs)

    Up to 5 years

  • Perioperative complications rate

    Up to 3 years

  • Health-related Quality of Life

    Up to 5 years

  • Perioperative pain evaluation

    Up to 3 years

  • +1 more secondary outcomes

Study Arms (1)

Patients with stage IIIB-C driver-negative NSCLC receiving induction chemoimmunotherapy

Diagnostic Test: NGS and ctDNA-MRD detection

Interventions

NGS and ctDNA-MRD detectionDIAGNOSTIC_TEST

NGS and ctDNA-MRD detection

Patients with stage IIIB-C driver-negative NSCLC receiving induction chemoimmunotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Potentially resectable stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy

You may qualify if:

  • Histopathology or cytology confirmed the non-small cell lung cancer
  • Age ranging from 18 to 75
  • Agree to participate in this study and sign an informed consent form
  • Treatment-naive tumor
  • Driver gene negativity
  • According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage IIIB-C potentially resectable tumor
  • The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0-1

You may not qualify if:

  • Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
  • Small cell lung cancer
  • Driver gene positivity
  • Tumor directly invades esophagus, heart, aorta, diaphragm, trachea, or carina, or is considered unresectable even following induction therapy
  • Patients with solid organ or blood system transplantation
  • Previous use of recombinant cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), programmed cell death 1 (PD-1), or programmed cell death ligand 1 (PD-L1) immune checkpoint inhibitors
  • Patients with interstitial lung disease
  • Patients with acute or chronic infectious disease
  • Pregnant and lactating women
  • Patients who have undergone other clinical drug trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Yan Hu, M.D., Ph.D.

CONTACT

8685296122yanhu@csu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2023

First Posted

April 20, 2023

Study Start

April 1, 2023

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

April 20, 2023

Record last verified: 2023-04

Locations

CN(1)