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

NCT06287320 | Recruiting DMC

• 1 other identifier: Bioplc
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Locally Advanced Non-small Cell Lung Cancer

Keywords

Peripheral blood lymphocyte subsets

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression-free survival (PFS)

  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.

• Overall survival (OS)

  From the date of first treatment to the date of any documented death due to any cause, assessed up to 24 months.

• Objective Response Rate (ORR)

  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.

• Disease control rate (DCR)

  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.

Study Arms (2)

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".

Radiation: concurrent or sequential chemoradiotherapy; Drug: Immunotherapy

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".

Radiation: concurrent or sequential chemoradiotherapy

Interventions

concurrent or sequential chemoradiotherapy RADIATION

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

NSCLC patients received CRT; NSCLC patients received CRT plus ICIs

Immunotherapy DRUG

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

NSCLC patients received CRT plus ICIs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive locally advanced NSCLC patients treated with definitive CRT with or without ICIs at hospital.

You may qualify if:

• Age 18-75 years; ECOG score 0-2.
• Pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system.
• Received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy.
• No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.

You may not qualify if:

• Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.
• Patients with other active malignancies within 5 years or at the same time.
• Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis \[except diverticular disease\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome).
• History of allogeneic organ transplantation.
• History of active primary immunodeficiency.
• 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.
• Women of child-bearing potential who are pregnant or breastfeeding.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

10 ml whole blood

MeSH Terms

Interventions

Immunotherapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Nan Bi, MD

  Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Bi, MD

CONTACT

8601087788799; binan_email@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: March 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)