Lung Cancer (NSCLC)NCT06953765
A Prospective Study: the Impact of Sleep Disturbances on Immunotherapy in Patients With Lung Cancer
An observational study of Lung Cancer (NSCLC) and Sleep Disorders, Circadian Rhythm, run by Shanghai Zhongshan Hospital.
Trial summary
In recent years, immunotherapy has made significant progress in the treatment of lung cancer, especially immune checkpoint inhibitors (such as PD-1/PD-L1 antibodies) against non-small cell lung cancer (NSCLC). However, there are significant individual differences in patient response to treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer (NSCLC), Sleep Disorders, Circadian Rhythm, PD-1
- What is being tested?
- PSQI and PQSI
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Dec 2028
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed primary lung cancer (confirmed histopathologically or cytologically) were enrolled at Zhong shan hospital fromJune 2025
Who may be able to join
- Diagnosis of non-small-cell lung cancer (stage II-IV) Age 18 and older Immune checkpoint inhibitor therapy (e.g., nivolumab, pembrolizumab, etc.) is planned.
- Be able to understand the study and provide informed consent
Who cannot join
- Coexisting serious mental illness (e.g., major depression, anxiety, etc.) Recent chemotherapy or radiotherapy Other serious comorbidities (e.g., heart disease, liver and kidney insufficiency)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
In recent years, immunotherapy has made significant progress in the treatment of lung cancer, especially immune checkpoint inhibitors (such as PD-1/PD-L1 antibodies) against non-small cell lung cancer (NSCLC). However, there are significant individual differences in patient response to treatment. Studies have shown that sleep disorders may affect the function of the immune system, thereby affecting tumor progression and treatment response. Therefore, the aim of this study was to evaluate the impact of sleep disturbances on lung cancer patients receiving immunotherapy.
Read the detailed description
Project title Association analysis between sleep disorders and tumor immunity in lung cancer: a prospective study Backgroundsleep disorders have been extensively studied in recent years and have been shown to be closely related to the development and prognosis of a variety of chronic diseases, including cancer. Especially in patients with lung cancer, sleep disorders may have an important impact on immune function, treatment response and patient survival. The changes of tumor immune microenvironment play an important role in the occurrence, development and response to immunotherapy of lung cancer. However, the relationship between sleep disorders and the tumor immune microenvironment of lung cancer has not been systematically explored. Therefore, the aim of this study was to evaluate the potential relationship between sleep disorders and tumor immunity in lung cancer and provide a new perspective for tumor immunotherapy strategies.
Aimsthe aim of this study was to evaluate the potential relationship between sleep disorders and tumor immunity in lung cancer and provide a new perspective on tumor immunotherapy strategies.
Primary outcome: Changes in tumor immune microenvironment: The effect of sleep disorders on tumor immune microenvironment was evaluated by immune cell infiltration analysis and immune marker expression level evaluation. Expression levels of immune checkpoint molecules: the changes of immune checkpoint molecules such as PD-1 and PD-L1 in tumor tissues of patients were detected.
Secondary outcomes:
The overall survival (OS) and progression-free survival (PFS) were analyzed. Biomarker changes: such as changes in the levels of cytokines (IL-6, TNF-α, etc.). Patient quality of life: The impact of sleep quality on patient general health was assessed using a standardized quality of life questionnaire.
Study DesignThis study was a single-center, prospective, observational cohort study, combining biomarker analysis with clinical follow-up.
The sample size estimate anticipated enrollment of 300 patients
Inclusion/Exclusion/Withdrawal Criteria Inclusion criteria:
Patients diagnosed with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).
Age: 18 to 70 years old. Patients were required to have stage I-IV disease at diagnosis and to have consented to participate in the study.
Patients had not received immunotherapy for 6 months before enrollment.
Exclusion criteria:
There were severe comorbidities (such as severe cardiovascular disease, end-stage liver and kidney disease, etc.).
Patients with psychiatric conditions or inability to complete sleep assessments.
Pregnant or lactating women. Patients who have received immunotherapy or other therapies that interfere with the immune microenvironment.
Prospective study period from July 2025 to December 2027: patient collection, outcome follow-up, data collection and analysis; January to June 2028: data analysis, paper writing July 2028 ~ December 2028: Submission of papers Statistical analysis plan Descriptive statistics: Descriptive statistical analysis was performed on the basic characteristics of patients, sleep quality scores, and immune markers.
Survival analysis: Kaplan-Meier survival curve was used to analyze the relationship between sleep quality and overall survival (OS) and progression-free survival (PFS) of lung cancer patients. log-rank test was used to compare the difference of survival time between different sleep quality groups.
Multivariate Cox regression analysis: the effect of sleep quality on immune microenvironment and survival outcome was further analyzed after adjusting for clinical covariates (such as age, gender, lung cancer stage, treatment regimen, etc.).
Immune cell infiltration analysis: The degree of immune cell infiltration in patients with different sleep quality was analyzed by immunohistochemistry and flow cytometry, and its relationship with immunotherapy response was explored.
- Conditions
- Lung Cancer (NSCLC), Sleep Disorders, Circadian Rhythm, PD-1
- Being tested
- PSQI, PQSI
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSQIOther
Prospective observational cohort study: Cohort o: Stratified according to baseline sleep disorder severity (PSQI score ≥7 vs. <7).
PQSIOther
PQSI-Sleep quality assessment scale
| Study group | Role | What they receive |
|---|---|---|
| lung cancer-sleep disorders | Lung cancer patients treated with PD1 immunotherapy were divided into sleep disorders and non-sleep disorders groups. Receives: Other: PSQI; Other: PQSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Pathological complete response (pCR)
Measured: From enrollment to the end of treatment at two years"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zilong Liu, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953765
- Sponsor's protocol ID
- 2025-4-24-Prospective-SD-PD1
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study: the Impact of Sleep Disturbances on Immunotherapy in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT06953765
- Acronym / sponsor ID
- 2025-4-24-Prospective-SD-PD1
- Conditions
- Lung Cancer (NSCLC), Sleep Disorders, Circadian Rhythm, PD-1
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 1 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.
In recent years, immunotherapy has made significant progress in the treatment of lung cancer, especially immune checkpoint inhibitors (such as PD-1/PD-L1 antibodies) against non-small cell lung cancer (NSCLC). However, there are significant individual differences in patient response to treatment. Studies have shown that sleep disorders may affect the function of the immune system, thereby affecting tumor progression and treatment response. Therefore, the aim of this study was to evaluate the impact of sleep disturbances on lung cancer patients receiving immunotherapy.
Detailed description
Project title Association analysis between sleep disorders and tumor immunity in lung cancer: a prospective study Backgroundsleep disorders have been extensively studied in recent years and have been shown to be closely related to the development and prognosis of a variety of chronic diseases, including cancer. Especially in patients with lung cancer, sleep disorders may have an important impact on immune function, treatment response and patient survival. The changes of tumor immune microenvironment play an important role in the occurrence, development and response to immunotherapy of lung cancer. However, the relationship between sleep disorders and the tumor immune microenvironment of lung cancer has not been systematically explored. Therefore, the aim of this study was to evaluate the potential relationship between sleep disorders and tumor immunity in lung cancer and provide a new perspective for tumor immunotherapy strategies.
Aimsthe aim of this study was to evaluate the potential relationship between sleep disorders and tumor immunity in lung cancer and provide a new perspective on tumor immunotherapy strategies.
Primary outcome: Changes in tumor immune microenvironment: The effect of sleep disorders on tumor immune microenvironment was evaluated by immune cell infiltration analysis and immune marker expression level evaluation. Expression levels of immune checkpoint molecules: the changes of immune checkpoint molecules such as PD-1 and PD-L1 in tumor tissues of patients were detected.
Secondary outcomes:
The overall survival (OS) and progression-free survival (PFS) were analyzed. Biomarker changes: such as changes in the levels of cytokines (IL-6, TNF-α, etc.). Patient quality of life: The impact of sleep quality on patient general health was assessed using a standardized quality of life questionnaire.
Study DesignThis study was a single-center, prospective, observational cohort study, combining biomarker analysis with clinical follow-up.
The sample size estimate anticipated enrollment of 300 patients
Inclusion/Exclusion/Withdrawal Criteria Inclusion criteria:
Patients diagnosed with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).
Age: 18 to 70 years old. Patients were required to have stage I-IV disease at diagnosis and to have consented to participate in the study.
Patients had not received immunotherapy for 6 months before enrollment.
Exclusion criteria:
There were severe comorbidities (such as severe cardiovascular disease, end-stage liver and kidney disease, etc.).
Patients with psychiatric conditions or inability to complete sleep assessments.
Pregnant or lactating women. Patients who have received immunotherapy or other therapies that interfere with the immune microenvironment.
Prospective study period from July 2025 to December 2027: patient collection, outcome follow-up, data collection and analysis; January to June 2028: data analysis, paper writing July 2028 ~ December 2028: Submission of papers Statistical analysis plan Descriptive statistics: Descriptive statistical analysis was performed on the basic characteristics of patients, sleep quality scores, and immune markers.
Survival analysis: Kaplan-Meier survival curve was used to analyze the relationship between sleep quality and overall survival (OS) and progression-free survival (PFS) of lung cancer patients. log-rank test was used to compare the difference of survival time between different sleep quality groups.
Multivariate Cox regression analysis: the effect of sleep quality on immune microenvironment and survival outcome was further analyzed after adjusting for clinical covariates (such as age, gender, lung cancer stage, treatment regimen, etc.).
Immune cell infiltration analysis: The degree of immune cell infiltration in patients with different sleep quality was analyzed by immunohistochemistry and flow cytometry, and its relationship with immunotherapy response was explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer-sleep disorders | – | Other: PSQI, Other: PQSILung cancer patients treated with PD1 immunotherapy were divided into sleep disorders and non-sleep disorders groups. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed primary lung cancer (confirmed histopathologically or cytologically) were enrolled at Zhong shan hospital fromJune 2025
Key inclusion criteria (2 listed)
- Diagnosis of non-small-cell lung cancer (stage II-IV) Age 18 and older Immune checkpoint inhibitor therapy (e.g., nivolumab, pembrolizumab, etc.) is planned.
- Be able to understand the study and provide informed consent
Key exclusion criteria (1 listed)
- Coexisting serious mental illness (e.g., major depression, anxiety, etc.) Recent chemotherapy or radiotherapy Other serious comorbidities (e.g., heart disease, liver and kidney insufficiency)
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 |
|---|---|---|
| PSQIProspective observational cohort study: Cohort o: Stratified according to baseline sleep disorder severity (PSQI score ≥7 vs. <7). | Other | lung cancer-sleep disorders |
| PQSIPQSI-Sleep quality assessment scale | Other | lung cancer-sleep disorders |
Primary outcome
pCR
Time frame: From enrollment to the end of treatment at two years"
Pathological complete response (pCR)
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 1 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Zilong Liu principal investigator
Shanghai Zhongshan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (NSCLC) and Sleep Disorders, Circadian Rhythm, run by Shanghai Zhongshan Hospital.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Pan Jiang (18201731016, jiang.pan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: From enrollment to the end of treatment at two years"). 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 1 May 2025.