ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFang Wu
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Clinically confirmed advanced NSCLC patients with long-term benefit after first-line immunotherapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ctDNA detection
Diagnostic testHigh-depth sequencing method is used to detecting ctDNA.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-informed group)1 intervention
Group B: Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-agnostic group)1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
The duration from study enrollment to disease progression or death, whichever occurs first.
Time frame
3 yearsSecondary outcomes
1
The correlation of ctDNA and risk of progression
The correlation of ctDNA and risk of progression during the erolled observation process
Time frame
3 years2
Lead time
Lead time defined as the interval between ctDNA detection and imaging of progression.
Time frame
3 years3
Incidence of adverse events
the incidence of adverse events during the whole observation time
Time frame
3 years4
Overall survival (OS)
Overall survival (OS) defined as the duration from study enrollment until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.
Time frame
3 yearsOther outcomes
1
Objective response rate (ORR)
ORR is defined as the proportion of study participants who achieve complete response (CR) or partial response (PR) among the total study participants.
Time frame
3 years2
Factors influencing ctDNA detection
Analyze the factors affecting ctDNA shedding and non-shedding.
Time frame
3 years3
Differences between ctDNA MRD and other peripheral blood biomarkers.
Differences between ctDNA MRD and other peripheral blood biomarkers.
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fang Wu
Lead sponsor
Second Xiangya Hospital of Central South University
Sponsor institution
Sun Yat-Sen University Cancer Center
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Fujian Cancer Hospital
Collaborator
Third Affiliated Hospital of Third Military Medical University
Collaborator
Xiangya Hospital of Central South University
Collaborator
Qinghai Province Fifth People's Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Zhejiang Provincial People's Hospital
Collaborator
Hunan Province Tumor Hospital
Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Zhejiang Cancer Hospital
Collaborator
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
Inner Mongolia People's Hospital
Collaborator
Guizhou Provincial People's Hospital
Collaborator
The Third Xiangya Hospital of Central South University
Collaborator
Yueyang Central Hospital
Collaborator
ZhuZhou Central Hospital
Collaborator
Zhangjiajie Affiliated Hospital of Hunan Normal University
Collaborator
Loudi Central Hospital
Collaborator
Chang Sha First Hospital
Collaborator
Source ClinicalTrials.gov