Health Trials

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 groups

Locations

1
Department of Oncology, The Second Xiangya Hospital, Central South University410011, ChangshaHunan, China

Sponsors and collaborators

Second Xiangya Hospital of Central South University

Lead sponsor

Source ClinicalTrials.gov