Clinical trial NCT06975384: The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer
Official title: The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Sleep Disturbance
Immune Checkpoint Inhibitors
Cancer, Treatment-Related
Keywords: Lung Cancer
Immune Checkpoint Inhibitors
Sleep Disturbance
Circadian Rhythm
Cancer Progression
Prognosis
Biomarker
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 1270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: This is the prospective, observational cohort study (Nezha) to explore the associations of sleep disturbance with progression, efficacy of ICIs and prognosis of Lung Cancer. This study will have 5 cohorts

* Cohort 1: A prospective, observational cohort study to explore the association between sleep disturbance and the efficacy of first-line treatment of ICIs in advanced NSCLC.
* Cohort 2: A prospective, observational cohort study to explore the association between sleep disturbance and the efficacy of first-line treatment of limited-stage and extensive-stage SCLC.
* Cohort 3: A prospective, observational cohort study to explore the association between sleep disturbance and the efficacy of neoadjuvant therapy of ICIs in resectable NSCLC.
* Cohort 4: A prospective, observational cohort study to explore the association of sleep disturbance with postoperative recurrence and prognosis in early-stage NSCLC receiving radical surgery.
* Cohort 5: A prospective observational cohort study to explore the association between sleep disturbance and the efficacy of first-line treatment of targeted therapy in advanced NSCLC.

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.

Primary outcomes:
measure: Cohort 1 & 5: Progression-free survival (PFS)
timeFrame: 3 years
measure: Cohort 2: Overall survival (OS)
timeFrame: 5 years
measure: Cohort 3: Event-free survival (EFS)
timeFrame: 3 years
measure: Cohort 4: Disease-free survival (DFS)
timeFrame: 5 years
Secondary outcomes:
measure: Cohort 2: Progression-free survival (PFS)
timeFrame: 3 years
measure: Cohort 1 & 3 & 4 & 5: Overall survival (OS)
timeFrame: 5 years
measure: Quality of life (QoL)
timeFrame: 5 years
measure: Cohort 1 & 2 & 5: Objective Response Rate (ORR)
timeFrame: 2 years
measure: Cohort 3: Pathologic complete response (pCR) rate
timeFrame: 3 years
measure: Cohort 3: Major pathologic response (MPR)
timeFrame: 3 years
Other outcomes:
measure: Gut microbiota signature
timeFrame: 5 years
measure: Tumor microenvironment signature
timeFrame: 5 years
measure: Peripheral blood biomarker and immune cells signature
timeFrame: 5 years
Locations:
city: Changsha
country: China
facility: Department of Oncology, The Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
References: