The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer

Launched by SECOND XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · May 9, 2025

Keywords

ClinConnect Summary

This clinical trial, called Nezha, is exploring how sleep disturbances may affect the treatment and outcomes of lung cancer, specifically for patients receiving new therapies called immune checkpoint inhibitors (ICIs). The study is looking at different groups of patients, including those with advanced non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC), to see how their sleep quality relates to their cancer treatment success and overall prognosis.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of lung cancer. They should not have received any prior treatment for their cancer and should meet specific health criteria, such as having a good performance status, meaning they can carry out daily activities without major issues. Participants will be monitored throughout the trial to assess their sleep and how well their treatment is working. This study is important because understanding the connection between sleep and cancer treatment could lead to better patient care and improved outcomes for those facing lung cancer.

Gender

ALL

Eligibility criteria

• Cohort 1:
• Inclusion Criteria:
• • 1. Age ≥ 18 years old;
• • 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 (PS) of 0-1;
• • 5. Treatment naïve;
• • 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 consent to participate in the study;
• Exclusion Criteria:
• • 1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) fusion and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
• • 2. Presence of other malignant tumors or malignant diseases within 3 years;
• • 3. Concurrent acute or chronic psychiatric disorders;
• • 4. Patients receiving sleep medication;
• • 5. Prior participation in other clinical drug trials;
• • 6. Symptomatic brain metastasis;
• • 7. Inability to complete scale assessments.
• Cohort 2:
• Inclusion Criteria:
• • 1. Age ≥ 18 years old;
• • 2. Histologically confirmed diagnosis of SCLC；
• • 3. Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;
• • 4. ECOG PS of 0-1;
• • 5. Treatment naïve;
• • 6. Presence of at least one measurable lesion according to the RECIST v1.1 ;
• • 7. Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
• • 8. Informed consent to participate in the study;
• Exclusion Criteria:
• • 1. Presence of other malignant tumors or malignant diseases within 3 years;
• • 2. Concurrent acute or chronic psychiatric disorders;
• • 3. Patients receiving sleep medication;
• • 4. Prior participation in other clinical drug trials;
• • 5. Symptomatic brain metastasis;
• • 6. Inability to complete scale assessments.
• Cohort 3:
• Inclusion Criteria:
• • 1. Age ≥18 years old;
• • 2. Pathologically diagnosed as NSCLC;
• • 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 v1.1;
• • 5. Treatment naïve;
• • 6. Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy as neoadjuvant therapy;
• • 7. Cardiopulmonary function can withstand surgery;
• • 8. Informed consent to participate in the study.
• Exclusion Criteria:
• • 1. EGFR-sensitizing mutation and/or ALK fusion and/or ROS1 fusion-positive;
• • 2. Presence of other malignant tumors or malignant diseases within 3 years;
• • 3. Concurrent acute or chronic psychiatric disorders;
• • 4. Patients receiving sleep medication;
• • 5. Prior participation in other clinical drug trials;
• • 6. Symptomatic brain metastasis;
• • 7. Inability to complete scale assessments.
• Cohort 4:
• Inclusion Criteria:
• • 1. Age ≥ 18 years old;
• • 2. Pathologically diagnosed as NSCLC;
• • 3. Pathologically stage confirmed as early stage of IA-IIIA;
• • 4. Available for tumor tissue samples;
• • 5. Treatment naïve;
• • 6. Receiving radical surgery;
• • 7. Informed consent to participate in the study;
• Exclusion Criteria:
• • 1. Presence of other malignant tumors or malignant diseases within 3 years;
• • 2. Concurrent acute or chronic psychiatric disorders;
• • 3. Patients receiving sleep medication;
• • 4. Prior participation in other clinical drug trials;
• • 5. Inability to complete scale assessments.
• Cohort 5:
• Inclusion Criteria:
• • 1. Age ≥ 18 years old;
• • 2. Histologically confirmed diagnosis of NSCLC;
• • 3. Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;
• • 4. ECOG PS of 0-1;
• • 5. Treatment naive;
• • 6. Presence of at least one measurable lesion according to the RECIST v1.1;
• • 7. Receiving targeted therapy or combination with chemotherapy;
• • 8. Informed consent to participate in the study;
• • 9. Driver gene-positive.
• Exclusion Criteria:
• • 1. Presence of other malignant tumors or malignant diseases within 3 years;
• • 2. Concurrent acute or chronic psychiatric disorders;
• • 3. Patients receiving sleep medication;
• • 4. Prior participation in other clinical drug trials;
• • 5. Symptomatic brain metastasis;
• • 6. Inability to complete scale assessments.