Detection of Minimal Residual Disease in Resectable Stage II-IIIB Non-small Cell Lung Cancer

NCT06267144 | Unknown

• 1 other identifier: 23K237-001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Predicting relapse and overall survival in potentially resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) patients remains challenging. It is now widely recognized that patients with detectable MRD have a worse prognosis than those with undetectable MRD. Therefore, investigators performed this prospective clinical trial to evaluate the predictive value of MRD with increased risk of relapse and improves prediction of outcome in potentially resectable Stage IIIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy. In this study, investigators will pay more attention to the long-term follow-up time and dynamic monitoring of MRD. The predictive value of MRD with Disease-free survival (DFS) rate was observed as the primary endpoint. Besides that, the correlation of MRD with major pathologic response (MPR) rate, pathologic complete response (pCR) rate，event-free survival(EFS) rate and overall survival (OS) were observed as the second endpoints. Investigators hope it will provide a new insight for these potentially resectable Stage IIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy.

Conditions

Lung Cancer

Keywords

Neoadjuvant; Non Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Event free survival(EFS)

  Defined as the time from randomization to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death

  Six months after the surgery

Secondary Outcomes (5)

• Overall Survival (OS)

  Six months after the surgery

• Objective Response Rate (ORR)

  Six months after the surgery

• Disease-Control Rate (DCR)

  Six months after the surgery

• Pathological complete response rate（PCR）

  At the end of 2-3 cycles of neoadjuvant therapy (each cycle is 21 days)

• Major pathological response rate (MPR)

  At the end of 2-3 cycles of neoadjuvant therapy (each cycle is 21 days)

Study Arms (1)

immunotherapy and chemotherapy

Participants received two to three cycles of neoadjuvant chemoimmunotherapy before surgery. Adjuvant chemotherapy was also administered for 2-3 cycles after surgery. In addition, MRD was detected within 30 days before surgery, 1 week after surgery, 1 month ±7days after surgery, 6 months after surgery.

Drug: Sintilimab plus chemotherapy

Interventions

Sintilimab plus chemotherapy DRUG

Sintilimab: 200 mg via intravenous infusion on Day 1 of each 21-day cycle for 2-3 cycles in the neoadjuvant therapy and the maintenance therapy. Chemotherapy drugs: carboplatin/cisplatin+Pemetrexed/gemcitabine/albuminpaclitaxel. Carboplatin: AUC 5 via intravenous infusion, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly. Cisplatin: 75 mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly. Pemetrexed: 500mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly. Gemcitabine:1.0g/m2 via intravenous infusion in day1 and day8, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly. Albuminpaclitaxel: 260 mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly.

immunotherapy and chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient initially diagnosed with resectable stage III-IIIA/IIIB non-small cell lung cancer t the First Hospital of Jilin University.

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2.
• Have previously untreated and histological examination confirms resectable stage II-IIIA/IIIB non-small cell lung cancer (according to the 8th edition of the AJCC TNM staging criteria), and the pathological type of squamous cell carcinoma and non-squamous cell carcinoma needs to be distinguished, and EGFR, ALK, and ROS1 should be negative for non-squamous non-small cell lung cancer
• Adequate organ function and expected survival time ≥ 12 weeks;
• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.

You may not qualify if:

• Presence of mixed carcinoma component on histology.
• Patients with other active malignancies within 5 years prior to enrollment.
• Known active autoimmune diseases.
• Currently participate in an interventional clinical study treatment or have been treated with another drug or investigational device within 4 weeks prior to the first dose.
• Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
• Presence of other uncontrolled serious medical conditions.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital Of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab; Drug Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Kewei Ma

CONTACT

0431-88782179; makw@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 20, 2024
• Study Start: January 20, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 17, 2025
• Last Updated: February 20, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)