NCT05477979 The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG)

Trial Parameters

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Brief Summary

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

Cohort 1 (STRESS-LUNG-1): Inclusion Criteria: 1. Age ≥ 18 years; 2. Histologically confirmed diagnosis of NSCLC; 3. Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy ); 6. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ; 7. Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy; 8. Informed and agreed to participate in the study; Exclusion Criteria: 1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) gene and/or ROS proto-oncogene 1 (ROS1) fusion-positive; 2. Combined with other malignant tumors in the past 3 years; 3. Concurrent acute or chronic psychiatric disorders; 4. Current receivi

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