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The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

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

The Peripheral Blood Lymphocyte Subsets as Predicative Biomarkers Reflecting the Efficacy and Toxicity in Patients With Locally Advanced Non-small Cell Lung Cancer Received Chemoradiotherapy With or Without Immunotherapy

NCT06287320•Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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).

Detailed 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

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 (including inflammatory bowel disease, diverticulitis \[except diverticular disease\], systemic lupus 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 to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental 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.

Locations (1)

Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, China

Key Dates

Start Date

March 1, 2024

Primary Completion Date

December 31, 2025

Completion Date

February 28, 2026

Last Updated

March 1, 2024

Enrollment

200

ESTIMATED participants

Conditions

Locally Advanced Non-small Cell Lung Cancer

Interventions

concurrent or sequential chemoradiotherapy

RADIATION

Immunotherapy

DRUG

Contacts

Nan Bi, MD

CONTACT

8601087788799 binan_email@163.com

RAPART in Locally Advanced Non-small Cell Lung Cancer Patients

NCT07164885

Locally Advanced Non-small Cell Lung Cancer

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RECRUITINGPHASE2

Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer

NCT06755684

EGFRNon-Small Cell Lung Cancer+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

RAPART in Locally Advanced Non-small Cell Lung Cancer Patients

Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer

A Phase II Trial of Cisplatin-Docetaxel Induction Plus Concurrent 3-D Conformal Radiotherapy and Weekly Chemotherapy