About this trial

This is the prospective, observational cohort study (STRESS-LUNG) to explore the associations of psychological stress 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 the first-line therapy or neoadjuvant therapy of ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early small-cell lung cancer (SCLC) receiving surgery.

Eligibility criteria

Qualifiers

Age ≥ 18 years;

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 of 0-1;

Disqualifiers

Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) gene and/or ROS proto-oncogene 1 (ROS1) fusion-positive;

Combined with other malignant tumors in the past 3 years;

Concurrent acute or chronic psychiatric disorders;

Current receiving anti-depressive or anti-anxiety therapy;

Trial design

Treatments tested in this trial

  • Exposure: psychological stress status

Treatment groups

750 Participants
are divided into 4 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

Central South University

Sponsor institution