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

Locally Advanced Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287320
• Other study ID #: Bioplc
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: January 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Nan Bi, MD
• Phone: 8601087788799
• Email: binan_email[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced Non-small Cell Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• concurrent or sequential chemoradiotherapy
Thoracic radiation therapy(with the prescribed dose of 50-70 Gy), concurrently or sequentially combined with platinum-based doublet chemotherapy.

Drug:
• Immunotherapy
anti-PD-1/anti-PD-L1 immune checkpoint inhibitors

Locations

Country	Name	City	State
China	Chinese Academy of Medical Science and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event	The incidence of adverse events (AEs) and serious adverse events (SAEs) is evaluated by CTCAE 5.0. Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse event will be calculated.	AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of study drug, up to 24 months.
Secondary	Progression-free survival (PFS)	Defined as the time from date of first treatment until the date of first documented progression or date of death from any cause, whichever came first.	From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Secondary	Overall survival (OS)	Defined as the time from the date of first treatment to the date of any documented death due to any cause.	From the date of first treatment to the date of any documented death due to any cause, assessed up to 24 months.
Secondary	Objective Response Rate (ORR)	The objective response rate (ORR) will be calculated as the number of patients with CR or PR per RECIST Criteria.; Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	Tumor assessment using RECIST will be performed at baseline then every 3 months from the first treatment until objective progression or death from any cause, assessed up to 24 months.
Secondary	Disease control rate (DCR)	DCR will be calculated as the number of patients with CR, PR or sustained SD=6 weeks per RECIST Criteria.; Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.	Tumour assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 24 months.