Analysis of Drug Resistance in Immune Checkpoint Inhibitors of Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04977791|
Recruitment Status : Recruiting
First Posted : July 27, 2021
Last Update Posted : July 27, 2021
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)
|Condition or disease||Intervention/treatment|
|Non-Small Cell Lung Cancer||Drug: Anti-PD-1/PD-L1 monoclonal antibody|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Molecular Landscape of Primary and Acquired Resistance to Immune Checkpoint Inhibitors in Patients With Chinese Advanced Non-small Cell Lung Cancer|
|Actual Study Start Date :||July 21, 2016|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 31, 2023|
- Drug: Anti-PD-1/PD-L1 monoclonal antibody
Observe a situation before and after immunotherapyOther Name: Immune checkpoint inhibitor
- Objective response rate (ORR) [ Time Frame: Up to 5 years ]The investigator (and the chief radiologist) used the RECIST 1.1 evaluation criteria to evaluate the efficacy indicators. CT or MRI imaging data of the chest and abdomen collected regularly during the screening/baseline period and the study period were used for tumor evaluation. Only when there may be primary or metastatic disease in the pelvis, pelvic imaging is recommended. Any other disease-affected areas (for example, the pelvis and brain) should undergo additional imaging studies based on the individual patient's signs and symptoms. If an unplanned evaluation is performed and it is shown that the patient has not progressed, follow-up evaluation should be performed at the next scheduled visit as much as possible. Scanning/tumor evaluation continued throughout the study period until RECIST 1.1 appeared
- Progression-free survival (PFS) [ Time Frame: Up to 5 years ]Calculate the time from the immunotherapy to the tumor progression/all-cause death/the end of the follow-up period.
- Overall survival (OS) [ Time Frame: Up to 5 years ]Calculate the time from the immunotherapy to the end of the all-cause death/follow-up period.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04977791
|Shanghai, Shanghai, China|
|Contact: Niu Xiaomin firstname.lastname@example.org|