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

NCT06975384 | Recruiting

• 1 other identifier: LYF20240270
• Study Type: observational
• Target: 1,270
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Cohort 1 & 5: Progression-free survival (PFS)

  Time from the beginning of first-line immunotherapy or targeted therapy to the first progression (PD).

  3 years

• Cohort 2: Overall survival (OS)

  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.

  5 years

• Cohort 3: Event-free survival (EFS)

  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.

  3 years

• Cohort 4: Disease-free survival (DFS)

  Duration between the date after surgery to the date of any recurrence or death firstly.

  5 years

Secondary Outcomes (6)

• Cohort 2: Progression-free survival (PFS)

  3 years

• Cohort 1 & 3 & 4 & 5: Overall survival (OS)

  5 years

• Quality of life (QoL)

  5 years

• Cohort 1 & 2 & 5: Objective Response Rate (ORR)

  2 years

• Cohort 3: Pathologic complete response (pCR) rate

  3 years

Other Outcomes (3)

• Gut microbiota signature

  5 years

• Tumor microenvironment signature

  5 years

• Peripheral blood biomarker and immune cells signature

  5 years

Study Arms (5)

Advanced NSCLC patients receiving first-line ICIs

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

Other: Exposure: sleep disturbance status

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.

Other: Exposure: sleep disturbance status

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.

Other: Exposure: sleep disturbance status

Early stage NSCLC patients receiving radical resection

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

Other: Exposure: sleep disturbance status

Advanced NSCLC patients receiving first-line targeted therapy

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

Other: Exposure: sleep disturbance status

Interventions

Exposure: sleep disturbance status 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 ICIs; Advanced NSCLC patients receiving first-line targeted therapy; Early stage NSCLC patients receiving radical resection; Limited-stage and extensive-stage SCLC patients receiving first-line ICIs; NSCLC patients receiving neoadjuvant therapy of ICIs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years old;
• Histologically confirmed diagnosis of NSCLC;
• Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;
• Treatment naïve;
• Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1);
• Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
• Informed consent to participate in the study;

You may not qualify if:

• Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) fusion and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
• Presence of other malignant tumors or malignant diseases within 3 years;
• Concurrent acute or chronic psychiatric disorders;
• Patients receiving sleep medication;
• Prior participation in other clinical drug trials;
• Symptomatic brain metastasis;
• Inability to complete scale assessments.
• Cohort 2:
• Age ≥ 18 years old;
• Histologically confirmed diagnosis of SCLC；
• Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;
• ECOG PS of 0-1;
• Treatment naïve;
• Presence of at least one measurable lesion according to the RECIST v1.1 ;
• Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

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

Changsha, Hunan, 410011, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

baseline tumor tissue, serial blood and stool samples (baseline and treatment follow-up time points).

MeSH Terms

Conditions

Lung Neoplasms; Parasomnias; Neoplasms, Second Primary; Disease Progression

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fang Wu, MD. PhD

CONTACT

+86 13574858332; wufang4461@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)