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

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.