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

Launched by SECOND XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Jul 26, 2022

Keywords

ClinConnect Summary

The STRESS-LUNG trial is a study designed to understand how psychological stress affects the treatment and outcomes of lung cancer. Specifically, it looks at patients with different types of lung cancer who are receiving a type of treatment called immune checkpoint inhibitors (ICIs). The goal is to see if stress impacts how well these treatments work and how patients do overall. The study includes adults aged 18 and older who have been diagnosed with either non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC), and who are starting their first round of treatment.

Eligible participants will need to meet certain criteria, such as having a specific stage of lung cancer and not having received prior treatments. They should also be in good enough health to participate in the study and not have any serious psychiatric disorders. Those who join the study can expect to share their experiences and complete some assessments about their stress levels. This research could help improve the understanding of how psychological factors influence cancer treatment, potentially leading to better care for lung cancer patients in the future.

Gender

ALL

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;