Last updated: February 23, 2024
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Immunotherapy
concurrent or sequential chemoradiotherapy
Clinical Study ID
NCT06287320
Bioplc
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18-75 years; ECOG score 0-2.
- Pathologically confirmed locally advanced NSCLC according to the 8th AJCC stagingsystem.
- Received definitive radiotherapy, concurrently or sequentially combined withplatinum-based doublet chemotherapy.
- No serious medical diseases and dysfunction of major organs, such as blood routine,liver, kidney, heart and lung function.
Exclusion
Exclusion Criteria:
- 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 (includinginflammatory bowel disease, diverticulitis [except diverticular disease], systemiclupus 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 topersistent or active infection (including tuberculosis, hepatitis B, hepatitis C,human immunodeficiency virus, etc.), symptomatic congestive heart failure,uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, activeinterstitial lung disease, severe chronic gastrointestinal disease with diarrhea ormental illness.
- Women of child-bearing potential who are pregnant or breastfeeding.
- The investigator judged other situations not suitable for inclusion in this study.
Study Design
Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Immunotherapy
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
February 28, 2026
Study Description
Connect with a study center
Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing 100021
ChinaActive - Recruiting

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