the associations of psychological stress with therapy efficacy and prognosis of lung cancer (stress-lung)

Conditions: Lung Cancer; Psychological Stress; Immune Checkpoint Inhibitors; Cancer, Treatment-Related

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.

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.

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 receiving anti-depressive or anti-anxiety therapy; 5. previous treatment with other clinical drug trials; 6. patients with symptomatic brain metastasis; 7. can't cooperate with psychological scale assessment; cohort 2 (stress-lung-2): 1. age ≥ 18 years； 2. pathologically diagnosed as small cell lung cancer； 3. unresectable locally advanced, metastatic, or recurrent stage ⅲ-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. combined with other malignant tumors in the past 3 years; 2. concurrent acute or chronic psychiatric disorders; 3. current receiving anti-depressive or anti-anxiety therapy; 4. previous treatment with other clinical drug trials; 5. patients with symptomatic brain metastasis; 6. can't cooperate with psychological scale assessment; cohort 3 (stress-lung-3): 1. age ≥18 years ； 2. pathologically diagnosed as non-small cell lung cancer; 3. resectable clinical stage ib-iiib based on ajcc tnm staging 8th edition; 4. at least one measurable lesion can be evaluated according to the recist 1.1 standard； 5. systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy ); 6. receiving pd-1/pd-l1 inhibitors combined with chemotherapy as neoadjuvant therapy. 6. cardiopulmonary function can withstand surgery; 7. 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 receiving anti-depressive or anti-anxiety therapy; 5. previous treatment with other clinical drug trials; 6. can't cooperate with psychological scale assessment; cohort 4 (stress-lung-4): 1. age ≥18 years; 2. pathologically diagnosed as non-small-cell lung cancer； 3. pathologically stage conformed as early stage of ia-iiia 4. available for tumor tissue samples； 5. systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy ); 6. receiving radical surgery; 7. informed and agreed to participate in the study; exclusion criteria: 1. combined with other malignant tumors in the past 3 years; 2. concurrent acute or chronic psychiatric disorders; 3. current receiving anti-depressive or anti-anxiety therapy; 4. previous treatment with other clinical drug trials; 5. can't cooperate with psychological scale assessment;

Keywords: lung cancer immune checkpoint inhibitors psychological stress cancer progression prognosis biomarker