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

Last updated: February 18, 2024
Sponsor: The First Hospital of Jilin University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Cancer

Lung Disease

Non-small Cell Lung Cancer

Treatment

Sintilimab plus chemotherapy

Clinical Study ID

NCT06267144
23K237-001
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2.
  • Have previously untreated and histological examination confirms resectable stageII-IIIA/IIIB non-small cell lung cancer (according to the 8th edition of the AJCC TNMstaging criteria), and the pathological type of squamous cell carcinoma andnon-squamous cell carcinoma needs to be distinguished, and EGFR, ALK, and ROS1 shouldbe 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 forfemale pre-menopausal patients.

Exclusion

Key Exclusion Criteria:

  • 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 beentreated with another drug or investigational device within 4 weeks prior to the firstdose.
  • Use of immunosuppressive agents within 14 days prior to the first dose of studytreatment.
  • Presence of other uncontrolled serious medical conditions.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Sintilimab plus chemotherapy
Phase:
Study Start date:
January 20, 2024
Estimated Completion Date:
December 17, 2025

Connect with a study center

  • The First Hospital Of Jilin University

    Changchun, Jilin 130000
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.