Evaluating blood markers in patients with advanced 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

This study is testing if certain blood markers can help predict how well treatment works and any side effects for people with advanced lung cancer receiving chemotherapy and possibly immunotherapy.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06287320 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess peripheral blood lymphocyte subsets as predictive biomarkers for efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) undergoing chemoradiotherapy, with or without immune checkpoint inhibitors. Patients will have their blood samples collected at various time points throughout their treatment to analyze lymphocyte subsets. The study will categorize participants based on whether they received immunotherapy alongside their treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed locally advanced NSCLC who are eligible for chemoradiotherapy.

Not a fit: Patients with specific genetic mutations like EGFR or ALK, or those with active autoimmune diseases, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify biomarkers that predict treatment responses and side effects in lung cancer patients.

How similar studies have performed: While the approach of using blood biomarkers in cancer treatment is not entirely novel, the specific focus on lymphocyte subsets in this context is relatively untested.

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.

Where this trial is running

Beijing, Beijing

• Chinese Academy of Medical Science and Peking Union Medical College — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Nan Bi, MD — Chinese Academy of Medical Sciences and Peking Union Medical College
• Study coordinator: Nan Bi, MD

Conditions: Locally Advanced Non-small Cell Lung Cancer, Peripheral blood lymphocyte subsets