ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC

Advanced Lung Non-Small Cell Carcinoma Clinical Trial

— CR1STAL  

Official title:

A Multicenter, Prospective Clinical Study of Circulating Tumor DNA Analysis to Monitor the Risk of Progression After Long-term Benefit to First-line Immunotherapy in Patients With Advanced NSCLC (CR1STAL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198154
• Other study ID #: XYEYY20211024
• Status: Recruiting
• Start date: January 24, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: January 2024
• Source: Second Xiangya Hospital of Central South University
• Contact: Chunhong Hu, professor
• Phone: +86 13508486908
• Email: huchunh5829[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

Description:

Evidence suggests that circulating tumor DNA (ctDNA) analysis can noninvasively identify minimal residual disease (MRD) in clinical oncology. The researches will be sharply increased about ctDNA potential clinical application in the near future. In the early stage of NSCLC, ctDNA has been indicated to identify those at high risk of recurrence after radical surgery. And this study will focus on those patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months). 10ml plasma will be collected every three months until disease progression to interrogate ctDNA by high-depth panel sequencing, exploring its prediction value about the risk of progression. Meanwhile, the investigators would like to explore the lead time of detectable ctDNA before regular imaging finding.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age from 18 to 75 years old
• Advanced non-small cell lung cancer (stage IIIB-IV), pathological types limited to squamous cell carcinoma or adenocarcinoma, 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%.
• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Advanced Lung Non-Small Cell Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Disease Progression

Intervention

Diagnostic Test:
• ctDNA detection
High-depth sequencing method is used to detecting ctDNA.

Locations

Country	Name	City	State
China	Oncology Department,Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (22)

Lead Sponsor

Collaborator

Fang Wu

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Chang Sha First Hospital, First Affiliated Hospital Xi'an Jiaotong University, Fujian Cancer Hospital, Guizhou Provincial People's Hospital, Hunan Province Tumor Hospital, Inner Mongolia People's Hospital, Loudi Central Hospital, Qinghai Province Tumor Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sun Yat-sen University, The First Affiliated Hospital of Guangzhou Medical University, The Third Xiangya Hospital of Central South University, Third Affiliated Hospital of Third Military Medical University, Wuhan Union Hospital, China, Xiangya Hospital of Central South University, Yueyang Central Hospital, Zhangjiajie Affiliated Hospital of Hunan Normal University, Zhejiang Cancer Hospital, Zhejiang Provincial People's Hospital, ZhuZhou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	Time from the beginning of first-line immunotherapy to the first progression(PD) in patients with advanced NSCLC.	3 years
Secondary	The correlation of ctDNA and risk of progression	The correlation of ctDNA and risk of progression during the erolled observation process	3 years
Secondary	Lead time	Lead time defined as the interval between ctDNA detection and imaging of progression.	3 years
Secondary	Incidence of adverse events	the incidence of adverse events during the whole observation time	3 years
Secondary	Overall survival (OS)	Overall survival (OS) defined as the duration from the beginning of first-line immunotherapy 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.	3 years