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

This is the prospective, observational cohort study (STRESS-LUNG) to explore the associations of psychological stress with progression, efficacy of ICIs and prognosis of Lung Cancer. This study will have 4 cohorts

• Cohort 1 (STRESS-LUNG-1): A prospective, observational cohort study to explore the association between psychological stress and the efficacy of first-line treatment of ICIs in advanced NSCLC.
• Cohort 2 (STRESS-LUNG-2): A prospective, observational cohort study to explore the association between psychological stress and the efficacy of first-line treatment of limited-stage and extensive-stage SCLC.
• Cohort 3 (STRESS-LUNG-3): A prospective, observational cohort study to explore the association between psychological stress and the efficacy of neoadjuvant therapy of ICIs in resectable NSCLC.
• Cohort 4 (STRESS-LUNG-4): A prospective, observational cohort study to explore the association of psychological stress with cancer progression, and Prognosis in early-stage NSCLC receiving radical surgery.

Cohort 1 (STRESS-LUNG-1):

Inclusion criteria

• 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;
• Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
• Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;
• Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
• Informed and agreed to participate in the study;

Exclusion criteria

• 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;
• Previous treatment with other clinical drug trials;
• Patients with symptomatic brain metastasis;
• Can't cooperate with psychological scale assessment;

Cohort 2 (STRESS-LUNG-2):

• Age ≥ 18 years；
• Pathologically diagnosed as small cell lung cancer；
• Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
• Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;
• Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
• Informed and agreed to participate in the study;

Exclusion criteria

• Combined with other malignant tumors in the past 3 years;
• Concurrent acute or chronic psychiatric disorders;
• Current receiving anti-depressive or anti-anxiety therapy;
• Previous treatment with other clinical drug trials;
• Patients with symptomatic brain metastasis;
• Can't cooperate with psychological scale assessment;

Cohort 3 (STRESS-LUNG-3):

• Age ≥18 years ；
• Pathologically diagnosed as non-small cell lung cancer;
• Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;
• At least one measurable lesion can be evaluated according to the RECIST 1.1 standard；
• Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
• Receiving PD-1/PD-L1 inhibitors combined with chemotherapy as neoadjuvant therapy.

• Cardiopulmonary function can withstand surgery; 7. Informed and agreed to participate in the study;

Exclusion criteria

• 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;
• Previous treatment with other clinical drug trials;
• Can't cooperate with psychological scale assessment;

Cohort 4 (STRESS-LUNG-4):

• Age ≥18 years;
• Pathologically diagnosed as non-small-cell lung cancer；
• Pathologically stage conformed as early stage of IA-IIIA
• Available for tumor tissue samples；
• Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
• Receiving radical surgery;
• Informed and agreed to participate in the study;

Exclusion criteria

• Combined with other malignant tumors in the past 3 years;
• Concurrent acute or chronic psychiatric disorders;
• Current receiving anti-depressive or anti-anxiety therapy;
• Previous treatment with other clinical drug trials;
• Can't cooperate with psychological scale assessment;