Exposure: sleep disturbance status: The assessment of sleep disturbance was conducted using Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI). Patients with a PSQI score \> 5 or an ISI score \> 7 were categorized as sleep disturbance patients.
The assessment of chronotype was conducted using reduced Morningness-Eveningness Questionnaire (rMEQ). Patients with an rMEQ score 18-25 were categorized as the morning type, those with an rMEQ score 12-17 as the intermediate type, and those with an rMEQ score 4-11 as the evening type.
Study summary
This is the prospective, observational cohort study (Nezha) to explore the associations of sleep disturbance 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 either first-line therapy (ICIs or targeted agents) or neoadjuvant therapy with ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early non-small-cell lung cancer (NSCLC) receiving surgery.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Cohort 1 & 5: Progression-free survival (PFS) — 3 years Time from the beginning of first-line immunotherapy or targeted therapy to the first progression (PD).
Cohort 2: Overall survival (OS) — 5 years Duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.
Cohort 3: Event-free survival (EFS) — 3 years Time from the start of initial treatment of immunotherapy to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death.
Cohort 4: Disease-free survival (DFS) — 5 years Duration between the date after surgery to the date of any recurrence or death firstly.
Trial sites (1)
Facility
City
Region
Status
Department of Oncology, The Second Xiangya Hospital, Central South University
Changsha
Hunan
Recruiting
More Second Xiangya Hospital of Central South University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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