Lung CancerNezhaNCT06975384
The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer
An observational study of Lung Cancer and Sleep Disturbance, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Sleep Disturbance, Immune Checkpoint Inhibitors
- What is being tested?
- Exposure: sleep disturbance status
- Type of treatment
- Injection or infusion
- How many people
- 1,270 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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);
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- Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
- Informed consent to participate in the study;
- 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;
- 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.
- 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;
- 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.
Who cannot join
- 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;
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- Inability to complete scale assessments.
- Cohort 2:
- 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:
- 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:
- 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:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Oncology, The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011
Fang Wu, MD, PhD, +86 13574858332, wufang4461@csu.edu.cn
About this study
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
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.
Read the 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.
- Being tested
- Exposure: sleep disturbance status
- Keywords
- Lung Cancer, Immune Checkpoint Inhibitors, Sleep Disturbance, Circadian Rhythm, Cancer Progression, Prognosis, Biomarker
- Medical subject headings
- Lung Neoplasms, Parasomnias, Neoplasms, Second Primary, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure: sleep disturbance statusOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Advanced NSCLC patients receiving first-line ICIs | For stage IIIB-IV patients with NSCLC who have received immune checkpoint inhibitors as first-line therapy. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Exposure: sleep disturbance status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1 & 5: Progression-free survival (PFS)
Time from the beginning of first-line immunotherapy or targeted therapy to the first progression (PD).
Measured: 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.
Measured: 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.
Measured: 3 years
Cohort 4: Disease-free survival (DFS)
Duration between the date after surgery to the date of any recurrence or death firstly.
Measured: 5 years
Secondary outcomes (6)
Cohort 2: Progression-free survival (PFS)
Time from the beginning of first-line immunotherapy to the first progression (PD).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 2 years
Cohort 3: Pathologic complete response (pCR) rate
pCR is no viable tumor cells in tumor bed and lymph nodes. The pCR rate is the proportion of patients with a pathologic complete response.
Measured: 3 years
Cohort 3: Major pathologic response (MPR)
MPR refers to the percentage of surviving tumor cells in the tumor bed after neoadjuvant therapy ≤10%, regardless of whether there are surviving tumor cells in the lymph nodes.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Nov 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,270 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Wu, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975384
- Sponsor's protocol ID
- LYF20240270
- Acronym
- Nezha
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06975384
- Acronym / sponsor ID
- Nezha / LYF20240270
- Keywords
- Lung Cancer, Immune Checkpoint Inhibitors, Sleep Disturbance, Circadian Rhythm, Cancer Progression, Prognosis, Biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,270 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Advanced NSCLC patients receiving first-line ICIs | – | Other: Exposure: sleep disturbance statusFor stage IIIB-IV patients with NSCLC who have received immune checkpoint inhibitors as first-line therapy. |
| Limited-stage and extensive-stage SCLC patients receiving first-line ICIs | – | Other: Exposure: sleep disturbance statusFor limited-stage and extensive-stage SCLC patients who have received immune checkpoint inhibitors as first-line therapy. |
| NSCLC patients receiving neoadjuvant therapy of ICIs | – | Other: Exposure: sleep disturbance statusFor stage IB-IIIB patients with non-small cell lung cancer who have received neoadjuvant therapy of immune checkpoint inhibitors. |
| Early stage NSCLC patients receiving radical resection | – | Other: Exposure: sleep disturbance statusFor early-stage patients with non-small cell lung cancer who have received radical resection. |
| Advanced NSCLC patients receiving first-line targeted therapy | – | Other: Exposure: sleep disturbance statusFor stage IIIB-IV patients with NSCLC who have received targeted agents as first-line therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (40 listed)
- 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;
Key exclusion criteria (35 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure: sleep disturbance statusThe 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. | Other | 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 |
Primary outcome
Cohort 1 & 5: Progression-free survival (PFS)
Time frame: 3 years
Time from the beginning of first-line immunotherapy or targeted therapy to the first progression (PD).
Cohort 2: Overall survival (OS)
Time frame: 5 years
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.
Cohort 3: Event-free survival (EFS)
Time frame: 3 years
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.
Cohort 4: Disease-free survival (DFS)
Time frame: 5 years
Duration between the date after surgery to the date of any recurrence or death firstly.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Sleep Disturbance, run by Second Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 40 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Wu, MD. PhD (+86 13574858332, wufang4461@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1 & 5: Progression-free survival (PFS) (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.