The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Xiangya Hospital of Central South University
About this trial
This is the prospective, observational cohort study (Nezha) to explore the associations of sleep disturbance with progression, efficacy of immune checkpoint inhibitors (ICIs) and prognosis of Lung Cancer. The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received either first-line therapy (ICIs or targeted agents) or neoadjuvant therapy with ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early non-small-cell lung cancer (NSCLC) receiving surgery.
Eligibility criteria
Qualifiers
Age ≥ 18 years old;
Histologically confirmed diagnosis of NSCLC;
Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;
Disqualifiers
Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) fusion and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
Presence of other malignant tumors or malignant diseases within 3 years;
Concurrent acute or chronic psychiatric disorders;
Patients receiving sleep medication;
Trial design
Treatments tested in this trial
- Exposure: sleep disturbance status
Treatment groups
1,270 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov