Non-small Cell Lung Cancer Clinical Trial
Official title:
Obstructive Sleep Apnea Influences Efficacy of Anti-Programmed-Death-1-Based Immunotherapy Against Non-Small Cell Lung Cancer - A Prospective Observational Cohort Study
This prospective, observational cohort study aims to explore the influence of obstructive sleep apnea(OSA) on the efficacy of PD-1-based immunotherapy in patients with non-small cell lung cancer(NSCLC). Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited. According to sleep monitor results, participants will be divided into Group NSCLC and Group OSA+NSCLC. Primary outcome is the objective remission rate(ORR).
This is a single-center, prospective, observational cohort study. Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited and followed for 4 years. According to the baseline sleep monitor results, participants will be divided into Group NSCLC(AHI<15), and Group OSA+NSCLC(AHIā„15), and then explore the influence of obstructive sleep apnea on the efficacy of PD-1-based immunotherapy. The baseline level of white blood cell count (WBC); absolute neutrophil count (ANC); absolute lymphocyte count (ALC); ANC to ALC (ANC:ALC) ratio; interleukin 6 (IL-6); C-reactive Protein (CRP) in peripheral blood, lymphocytes classification and count by flow cytometry, and gut microbiome analysis by quantitative metagenomics will also be measured to further search for the possible mechanisms. Primary outcome is the objective remission rate (ORR), secondary outcomes include overall survival (OS) and progression free survival (PFS). The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB). Any protocol modifications will be submitted for the IRB review and approval. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03087448 -
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
| Recruiting |
NCT05042375 -
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Terminated |
NCT05414123 -
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
|
||
| Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
| Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
| Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
|
Phase 3 | |
| Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT03219970 -
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
|
||
| Recruiting |
NCT05949619 -
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
|
Phase 2 | |
| Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
|
||
| Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
| Terminated |
NCT02580708 -
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01871805 -
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/Phase 2 | |
| Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
|
||
| Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
|
Phase 1 |