NCT05441566

Significance of MRD After Surgery in Driver Gene-positive and Driver Gene-negative Stage IB-IIA NSCLC

ENROLLING BY INVITATION Last updated 1 July 2022

What this trial tests

trial in NSCLC MRD ctDNA in 60 participants. Enrolling by invitation.

Timeline

1 June 2022

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Shenzhen People's Hospital
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	60
Start date	1 June 2022
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across China

Conditions studied

• NSCLC MRD ctDNA — all drugs for NSCLC MRD ctDNA →

Sponsor

Shenzhen People's Hospital

Who can join

Adults 18 to 100, any sex, with NSCLC MRD ctDNA. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1\. It has been controversial whether adjuvant therapy should be done for patients with stage IB NSCLC after surgery in clinical practice, and identifying patients with high-risk recurrence and those who can benefit from adjuvant therapy is an important clinical problem to be solved. Therefore, the first key scientific issue to be solved in this topic is to analyze the correlation between MRD detection results and both recurrence and adjuvant therapy efficacy by focusing on the stage IB-IIA postoperative NSCLC patient population. To provide clinical data to aid clinical screening of NSCLC patients at high risk of recurrence after surgery in stage IB-IIA.

2, if the detection of MRD has important clinical value such as accurately identifying the population at high risk of recurrence of stage IB-IIA NSCLC, the differences in MRD, etc. between driver gene-positive and -negative patients require further comparative analysis. The second key scientific issue to be solved in this topic is: the different role of MRD in driver gene-positive and driver gene-negative patients: comparison of positive rates, analysis of prognostic differences; and providing clinical data for elucidating the differences between driver gene-positive and -negative patients in MRD evaluation of lung cancer.

3\. If MRD is different between NSCLC patients with positive and negative driver genes in stage IB-IIA, is there a difference in the biological behavior of the tumors themselves between these two types of patients? Is there a difference in the ability of the tumor tissue itself to shed tumor cells to be released into the blood? The third scientific question to be addressed in this project is to explore the difference in the ability of patients with stage IB-IIA NSCLC to release ctDNA from their tumors by analyzing the correlation between detailed clinicopathological data and MRD. To provide a scientific basis for exploring the differences in tumor biological behavior between NSCLC driver gene positive and negative.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Drug development and evidence for lung cancer targeted therapy in Eastern Asia.
   Maggie Liu SY, Jin ZY, Deng JY, Zhong SM, et al · · 2024 · cited 2× · PMID 39381018 · DOI 10.1016/j.lanwpc.2024.101090
2. Clinical applications of circulating biomarkers in non-small cell lung cancer.
   Oh HJ, Imam-Aliagan AB, Kim YB, Kim HJ, et al · · 2024 · cited 1× · PMID 39239557 · DOI 10.3389/fcell.2024.1449232