Clinical trial NCT06287320: The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Locally Advanced Non-small Cell Lung Cancer
Keywords: Peripheral blood lymphocyte subsets
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive locally advanced NSCLC patients treated with definitive CRT with or without ICIs at hospital.

Brief 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 criteria: 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.

Primary outcomes:
measure: Adverse Event
timeFrame: AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of study drug, up to 24 months.
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 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.
measure: Overall survival (OS)
timeFrame: From the date of first treatment to the date of any documented death due to any cause, assessed up to 24 months.
measure: Objective Response Rate (ORR)
timeFrame: 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.
measure: Disease control rate (DCR)
timeFrame: 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.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Science and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences and Peking Union Medical College
name: Nan Bi, MD
role: PRINCIPAL_INVESTIGATOR
References: