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

ConditionsLung Cancer Sleep Disturbance Immune Checkpoint Inhibitors Cancer, Treatment-Related

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorSecond Xiangya Hospital of Central South University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Exposure: sleep disturbance status
Other intervention
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.

Treatment groups

1,270 Participants

are divided into 5 treatment groups

Group A: Advanced NSCLC patients receiving first-line ICIs1 intervention

Group B: Limited-stage and extensive-stage SCLC patients receiving first-line ICIs1 intervention

Group C: NSCLC patients receiving neoadjuvant therapy of ICIs1 intervention

Group D: Early stage NSCLC patients receiving radical resection1 intervention

Group E: Advanced NSCLC patients receiving first-line targeted therapy1 intervention

Trial outcomes

Primary outcomes

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

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

Time frame

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.

Time frame

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.

Time frame

3 years

Cohort 4: Disease-free survival (DFS)

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

Time frame

5 years

Secondary outcomes

Cohort 2: Progression-free survival (PFS)

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

Time frame

3 years

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

Overall Survival (OS) is defined as the duration from the start of initial treatment (systemic treatment or radical therapy) until death from 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.

Time frame

5 years

Quality of life (QoL)

Quality of life (QoL) is assessed longitude by EORTC QLQ-C30 (version.3). The EORTC QLQ-C30 is composed of 9 multi-item scales: 5 functioning scales (physical, role, cognitive, emotional, and social), a global QOL scale, and 3 symptom scales (fatigue, pain, and nausea/vomiting). All scales and single items are linearly transformed to an 0-100 scale. A higher score represents a better level of functioning.

Time frame

5 years

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

The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Time frame

2 years

Other outcomes

Gut microbiota signature

The baseline fetal is collected and assessed by 16S rRNA sequencing to explore the association between gut microbiota, states of sleep disturbance and efficacy and prognosis.

Time frame

5 years

Tumor microenvironment signature

The baseline paraffin-embedded tissue is collected and assessed by multiplex immunohistochemistry, single-cell sequencing, and spatial transcriptome sequencing to explore the association between tumor microenvironment signature, states of sleep disturbance and efficacy and prognosis.

Time frame

5 years

Peripheral blood biomarker and immune cells signature

The baseline peripheral venous blood is collected. Sleep-related biomarkers (including melatonin, epinephrine, norepinephrine, cortisol, serotonin, dopamine, and endorphins) are measured. The peripheral immune cells signature is assessed by flow cytometry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and dendritic cells (DCs). And explore the associations between peripheral blood biomarkers, immune cells signature, states of sleep disturbance and efficacy and prognosis.

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Xiangya Hospital of Central South University

Lead sponsor

Source ClinicalTrials.gov

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