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

NCT06198868 | Recruiting

• 1 other identifier: 2023K-011
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; Minimal Residual Disease; Prognosis monitoring; Adjuvant treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 )

Study Arms (2)

Operable group

Early-stage patients with radical surgery or operable patients with neoadjuvant treatment

Procedure: Operable

Inoperable group

Advanced-stage patients receive non-surgery therapies.

Interventions

Operable PROCEDURE

Enrolled patients capable of surgical treatment

Operable group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Written informed consent must be signed before implementing any enrollment-related procedures;
• Age ≥18 years old;
• 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)；
• There is no special restriction on the source of genetic test report.
• According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one radiographically measurable lesion.
• Have not received any previous systemic antitumor therapy for advanced diseases.
• No serious abnormalities of hematopoietic function, heart, lung, liver, kidney function and immune system.
• ECOG score: 0-1;
• Expected survival time \> 3 months.

You may not qualify if:

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

Sponsors & Collaborators

• Jiangsu Cancer Institute & Hospital: lead

Study Sites (1)

Jiangsu Cancer Institute & Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral whole blood

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rong Yin, M.D., Ph.D.

CONTACT

18305185629; rong_yin@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 10, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)