Actively Recruiting
Analysis of Drug Resistance in Immune Checkpoint Inhibitors of Non-small Cell Lung Cancer
Led by Shanghai Chest Hospital · Updated on 2025-05-22
250
Participants Needed
1
Research Sites
649 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Immunotherapy has improved the prognosis of non-small cell lung cancer (NSCLC) patients, but about 80% of patients do not respond at all, which is called primary resistance. Absence of the PD-L1 expression is regarded as one of primary resistant reasons to immunotherapy, there are some other reasons which have been reported to be related with the primary resistance, including tumor mutation burden (TMB), microsatellite instability (MSI), tumor neoantigen burden (TNB), HLA genotype, loss of heterozygosity (LOH), intra tumoral heterogeneity (ITH), genome wide doubling (WGD), and ploidy. While some patients initially respond to immunotherapy, later relapse and develop disease progression, which is called acquired resistance, like escaping of interferon signaling pathways or mutations in some important genes such as B2M/JAK1/JAK2. So the objective of this research is to explore the comprehensive immune molecular markers of primary and acquired resistance to immunotherapy in patients with Chinese advanced NSCLC based on the results of whole exome sequencing (WES) and targeted sequencing (TS)
CONDITIONS
Official Title
Analysis of Drug Resistance in Immune Checkpoint Inhibitors of Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent and agree to follow the research requirements
- Diagnosed with advanced non-small cell lung cancer
- Receiving immune checkpoint inhibitor treatment with anti-PD-1/PD-L1 monoclonal antibody
- Able to provide fresh tumor tissue samples before and after treatment or archived tumor tissue within one year, plus matched blood samples
- ECOG physical fitness status of 1 or less
- At least one measurable lesion according to RECIST v1.1
- Life expectancy of at least 12 weeks
- Adequate organ function including specific blood counts and liver function within 7 days before treatment
You will not qualify if you...
- Presence of other tumors, except certain skin cancers and cervical cancer in situ if treated and without relapse for 5 years
- Prior systemic anti-tumor immunotherapy before this study
- History of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases such as diabetes, hypertension, or pulmonary fibrosis
- Severe chronic or active infections requiring systemic therapy, including tuberculosis
- Known HIV infection, previous allogeneic stem cell or organ transplantation
- Investigator's judgment of insufficient compliance during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xiaomin Niu
Shanghai, Shanghai Municipality, China
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here