The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer

Last updated: February 23, 2024
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Immunotherapy

concurrent or sequential chemoradiotherapy

Clinical Study ID

NCT06287320
Bioplc
  • Ages 18-75
  • All Genders

Study Summary

This study is a prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-75 years; ECOG score 0-2.
  2. Pathologically confirmed locally advanced NSCLC according to the 8th AJCC stagingsystem.
  3. Received definitive radiotherapy, concurrently or sequentially combined withplatinum-based doublet chemotherapy.
  4. No serious medical diseases and dysfunction of major organs, such as blood routine,liver, kidney, heart and lung function.

Exclusion

Exclusion Criteria:

  1. Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.
  2. Patients with other active malignancies within 5 years or at the same time.
  3. Active or previously documented autoimmune or inflammatory diseases (includinginflammatory bowel disease, diverticulitis [except diverticular disease], systemiclupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome).
  4. History of allogeneic organ transplantation.
  5. History of active primary immunodeficiency.
  6. Patients with uncontrolled concurrent diseases, including but not limited topersistent or active infection (including tuberculosis, hepatitis B, hepatitis C,human immunodeficiency virus, etc.), symptomatic congestive heart failure,uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, activeinterstitial lung disease, severe chronic gastrointestinal disease with diarrhea ormental illness.
  7. Women of child-bearing potential who are pregnant or breastfeeding.
  8. The investigator judged other situations not suitable for inclusion in this study.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Immunotherapy
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
February 28, 2026

Study Description

All patients had a pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system and received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy. The peripheral blood samples at various time points including before radiation, 4 weeks after beginning of radiation, the end of radiation, 1 month post radiation, and 1 month post consolidation immunotherapy were collected for lymphocyte subsets detection.

The subjects will be divided into two groups according to whether patients received ICIs, namely, NSCLC patients received CRT plus ICIs and NSCLC patients received CRT.

Connect with a study center

  • Chinese Academy of Medical Science and Peking Union Medical College

    Beijing, Beijing 100021
    China

    Active - Recruiting

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