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

NCT ID: NCT06287320

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-02-28

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.

Conditions

Locally Advanced Non-small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NSCLC patients received CRT plus ICIs

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".

concurrent or sequential chemoradiotherapy

Intervention Type: RADIATION

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

Immunotherapy

Intervention Type: DRUG

anti-PD-1/anti-PD-L1 immune checkpoint inhibitors

NSCLC patients received CRT

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

concurrent or sequential chemoradiotherapy

Intervention Type: RADIATION

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

Interventions

concurrent or sequential chemoradiotherapy

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

Intervention Type: RADIATION

Immunotherapy

anti-PD-1/anti-PD-L1 immune checkpoint inhibitors

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nan Bi, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences and Peking Union Medical College

Locations

Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Nan Bi, MD

Role: CONTACT

binan_email@163.com

8601087788799

Facility Contacts

Nan Bi, MD, PhD

Role: primary

binan_email@163.com

Other Identifiers

Bioplc

Identifier Type: -

Identifier Source: org_study_id