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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Locally Advanced Non-small Cell Lung Cancer

Treatments: Radiation: concurrent or sequential chemoradiotherapy; Drug: Immunotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06287320

Bioplc

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

200 participants in 2 patient groups

NSCLC patients received CRT plus ICIs

Description:

For it's an observational study, locally advanced NSCLC patients received CRT with induction immunotherapy or consolidation immunotherapy will be divided into the group "NSCLC patients received CRT plus ICIs".

Treatment:

Drug: Immunotherapy

Radiation: concurrent or sequential chemoradiotherapy

NSCLC patients received CRT

Description:

For it's an observational study, locally advanced NSCLC patients received CRT without immunotherapy will be divided into the group "NSCLC patients received CRT".

Treatment:

Radiation: concurrent or sequential chemoradiotherapy