Clinical trial NCT06198868: MRD-guided Prognosis Prediction and Adjuvant Treatment Based on CTC and ctDNA in NSCLC
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
Minimal Residual Disease
Prognosis monitoring
Adjuvant treatment
Lead sponsor: Jiangsu Cancer Institute & Hospital
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 60 patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC would be enrolled from Jiangsu Cancer Institute \& Hospital. In resectable group, we would enroll 20 early-stage cases and 20 operable patients for neoadjuvant treatment . In non-resectable group, 20 advanced-stage inoperable patients would be enrolled.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the Progression-free Survival (PFS)
timeFrame: 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 outcomes:
measure: To evaluate the Overall Survival (OS)
timeFrame: From the date of first dose of study drug until date of death from any cause (up to approximately 5 years )
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Cancer Institute & Hospital
state: Jiangsu
Study officials:
References: