MRD-guided Prognosis Prediction and Adjuvant Treatment Based on CTC and ctDNA in NSCLC

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Procedure: Operable

• Registration Number: NCT06198868
• Lead Sponsor: Jiangsu Cancer Institute & Hospital

Brief Summary

This is a prospective cohort study, which aims to evaluate the effectiveness and superiority of a novel minimal residual disease-guided prognosis monitoring and adjuvant treatment in stage IIA-IIIC non-small cell lung cancer.

Detailed Description

This observational study is a single-center, prospective cohort study, which aims to detect minimal residual disease (MRD) using circulating tumor cells (CTC) and circulating tumor DNA (ctDNA). To evaluate the effectiveness and superiority of MRD detection, we enroll operable or inoperable IIA-IIIC stage NSCLC patients, and single-cell RNA sequencing and genomic sequencing would be performed for CTC and ctDNA, respectively.

Study Timeline

• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2023-12-28
• Status Verified: 2024-01
• Study First Posted: 2024-01-10
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12
• Study Start: 2024-02-01
• Primary Completion: 2026-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Written informed consent must be signed before implementing any enrollment-related procedures;
2. Age ≥18 years old;
3. Patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging)；
4. There is no special restriction on the source of genetic test report.
5. According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one radiographically measurable lesion.
6. Have not received any previous systemic antitumor therapy for advanced diseases.
7. No serious abnormalities of hematopoietic function, heart, lung, liver, kidney function and immune system.
8. ECOG score: 0-1;
9. Expected survival time > 3 months.

Exclusion Criteria

1. Received surgical treatment for lung tumors.
2. Received neoadjuvant chemotherapy or radiotherapy.
3. Received cellular therapy within the last 1 year.
4. Treated but uncontrolled diabetes, mellitus, asthma, autoimmune diseases and other chronic diseases.
5. Participated in other clinical trials (including research vaccines, drugs, medical devices, etc.) within one month.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Operable group	Operable	Early-stage patients with radical surgery or operable patients with neoadjuvant treatment

Primary Outcome Measures

Name	Time	Method
To evaluate the Progression-free Survival (PFS)	From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first), up to approximately 3 years	Progression-free survival (PFS) is defined as the time from the start of treatment to the occurrence of tumor progression or death due to any cause based on RECIST 1.1 assessed by investigator review.

Secondary Outcome Measures

Name	Time	Method
To evaluate the Overall Survival (OS)	From the date of first dose of study drug until date of death from any cause (up to approximately 5 years )	Overall Survival (OS) was measured from the date of first dose of study drug until date of death from any cause. Participants who were lost to follow-up and the participants who were alive at the date of data cutoff was censored at the date the participant was last known alive, whichever came earlier.

Trial Locations

Locations (1)

Jiangsu Cancer Institute & Hospital; 🇨🇳 Nanjing, Jiangsu, China