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

Non-small Cell Lung Cancer Clinical Trial

Official title:

Minimal Residual Disease (MRD) Guided Prognosis Prediction and Adjuvant Treatment Based on Expression and Mutational Signatures of Circulating Tumor Cell (CTC) and Circulating Tumor DNA (ctDNA) in Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06198868
• Other study ID #: 2023K-011
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: January 2024
• Source: Jiangsu Cancer Institute & Hospital
• Contact: Rong Yin, M.D., Ph.D.
• Phone: 18305185629
• Email: rong_yin[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Procedure:
• Operable
Enrolled patients capable of surgical treatment

Locations

Country	Name	City	State
China	Jiangsu Cancer Institute & Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Cancer Institute & Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the Progression-free Survival (PFS)	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.	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
Secondary	To evaluate the Overall Survival (OS)	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.	From the date of first dose of study drug until date of death from any cause (up to approximately 5 years )