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Recruiting NCT06975384

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

— Observational Lung Cancer Sleep Disturbance Immune Checkpoint Inhibitors Cancer, Treatment-Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exposure: sleep disturbance status.
Who it may be relevant to
Registry conditions: Lung Cancer, Sleep Disturbance, Immune Checkpoint Inhibitors, Cancer, Treatment-Related. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other 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

Primary outcome measures

  • Cohort 1 & 5: Progression-free survival (PFS) [Time frame: 3 years]
  • Cohort 2: Overall survival (OS) [Time frame: 5 years]
  • Cohort 3: Event-free survival (EFS) [Time frame: 3 years]
  • Cohort 4: Disease-free survival (DFS) [Time frame: 5 years]
Secondary outcome measures (6)
  • Cohort 2: Progression-free survival (PFS) [Time frame: 3 years]
  • Cohort 1 & 3 & 4 & 5: Overall survival (OS) [Time frame: 5 years]
  • Quality of life (QoL) [Time frame: 5 years]
  • Cohort 1 & 2 & 5: Objective Response Rate (ORR) [Time frame: 2 years]
  • Cohort 3: Pathologic complete response (pCR) rate [Time frame: 3 years]
  • Cohort 3: Major pathologic response (MPR) [Time frame: 3 years]

Eligibility criteria

Cohort 1:

Inclusion criteria

  • 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;

Exclusion criteria

  • 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:

Inclusion criteria

  • 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;
  • Informed consent to participate in the study;

Exclusion criteria

  • 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 3:

Inclusion criteria

  • Age ≥18 years old;
  • Pathologically diagnosed as NSCLC;
  • Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;
  • At least one measurable lesion can be evaluated according to the RECIST v1.1;
  • Treatment naïve;
  • Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy as neoadjuvant therapy;
  • Cardiopulmonary function can withstand surgery;
  • Informed consent to participate in the study.

Exclusion criteria

  • EGFR-sensitizing mutation and/or ALK fusion and/or 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 4:

Inclusion criteria

  • Age ≥ 18 years old;
  • Pathologically diagnosed as NSCLC;
  • Pathologically stage confirmed as early stage of IA-IIIA;
  • Available for tumor tissue samples;
  • Treatment naïve;
  • Receiving radical surgery;
  • Informed consent to participate in the study;

Exclusion criteria

  • 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;
  • Inability to complete scale assessments.

Cohort 5:

Inclusion criteria

  • 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;
  • ECOG PS of 0-1;
  • Treatment naive;
  • Presence of at least one measurable lesion according to the RECIST v1.1;
  • Receiving targeted therapy or combination with chemotherapy;
  • Informed consent to participate in the study;
  • Driver gene-positive.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Oncology, The Second Xiangya Hospital, Central South University — Changsha

Identifiers

NCT: NCT06975384 · LYF20240270

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗