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

NCT ID: NCT06975384

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2030-12-31

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.

Conditions

Lung Cancer; Sleep Disturbance; Immune Checkpoint Inhibitors; Cancer, Treatment-Related

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Advanced NSCLC patients receiving first-line ICIs

For stage IIIB-IV patients with NSCLC who have received immune checkpoint inhibitors as first-line therapy.

Exposure: sleep disturbance status

Intervention Type: OTHER

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.

Limited-stage and extensive-stage SCLC patients receiving first-line ICIs

For limited-stage and extensive-stage SCLC patients who have received immune checkpoint inhibitors as first-line therapy.

Exposure: sleep disturbance status

Intervention Type: OTHER

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.

NSCLC patients receiving neoadjuvant therapy of ICIs

For stage IB-IIIB patients with non-small cell lung cancer who have received neoadjuvant therapy of immune checkpoint inhibitors.

Exposure: sleep disturbance status

Intervention Type: OTHER

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.

Early stage NSCLC patients receiving radical resection

For early-stage patients with non-small cell lung cancer who have received radical resection.

Exposure: sleep disturbance status

Intervention Type: OTHER

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.

Advanced NSCLC patients receiving first-line targeted therapy

For stage IIIB-IV patients with NSCLC who have received targeted agents as first-line therapy.

Exposure: sleep disturbance status

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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;

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;

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.

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;

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. 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:

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:

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:

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Fang Wu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Oncology, The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fang Wu, MD. PhD

Role: CONTACT

wufang4461@csu.edu.cn

+86 13574858332

Facility Contacts

Fang Wu, MD, PhD

Role: primary

wufang4461@csu.edu.cn

+86 13574858332

Other Identifiers

LYF20240270

Identifier Type: -

Identifier Source: org_study_id