Obstructive Sleep ApneaNCT04743752
Obstructive Sleep Apnea Influences Efficacy of PD-1-Based Immunotherapy Against Non-Small Cell Lung Cancer
An observational study of Obstructive Sleep Apnea and Non-small Cell Lung Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
This prospective, observational cohort study aims to explore the influence of obstructive sleep apnea(OSA) on the efficacy of PD-1-based immunotherapy in patients with non-small cell lung cancer(NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Non-small Cell Lung Cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited and followed for 4 years.
Who may be able to join
- Histologically or cytologically confirmed, advanced NSCLC
- Participants with no prior treatment for advanced NSCLC
- Measurable disease as defined by RECIST v1.1
- Eligible to receive first-line treatment including PD-1 antibody
- Adequate hematologic and end organ function
Who cannot join
- Severe infection within 4 weeks prior to recruitment.
- Significant organ dysfunction or other serious diseases.
- Previous or current OSA related treatment, including oral appliance, surgery, mechanical ventilation therapy.
- Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jing Ma, Doctor, +8613651357974, majjmail@163.com
About this study
Official title: Obstructive Sleep Apnea Influences Efficacy of Anti-Programmed-Death-1-Based Immunotherapy Against Non-Small Cell Lung Cancer - A Prospective Observational Cohort Study
This prospective, observational cohort study aims to explore the influence of obstructive sleep apnea(OSA) on the efficacy of PD-1-based immunotherapy in patients with non-small cell lung cancer(NSCLC). Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited. According to sleep monitor results, participants will be divided into Group NSCLC and Group OSA+NSCLC. Primary outcome is the objective remission rate(ORR).
Read the detailed description
This is a single-center, prospective, observational cohort study. Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited and followed for 4 years. According to the baseline sleep monitor results, participants will be divided into Group NSCLC(AHI<15), and Group OSA+NSCLC(AHI≥15), and then explore the influence of obstructive sleep apnea on the efficacy of PD-1-based immunotherapy. The baseline level of white blood cell count (WBC); absolute neutrophil count (ANC); absolute lymphocyte count (ALC); ANC to ALC (ANC:ALC) ratio; interleukin 6 (IL-6); C-reactive Protein (CRP) in peripheral blood, lymphocytes classification and count by flow cytometry, and gut microbiome analysis by quantitative metagenomics will also be measured to further search for the possible mechanisms. Primary outcome is the objective remission rate (ORR), secondary outcomes include overall survival (OS) and progression free survival (PFS).
The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB). Any protocol modifications will be submitted for the IRB review and approval.
- Medical subject headings
- Sleep Apnea, Obstructive, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group OSA+NSCLC | According to the baseline sleep monitor results, participants will be divided into Group OSA+NSCLC if apnea hypopnea index(AHI) no less than 15. | |
| Group NSCLC | According to the baseline sleep monitor results, participants will be divided into Group NSCLC if apnea hypopnea index(AHI) less than 15. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
ORR, the percentage of complete response (CR) or partial response (PR) according to RECIST 1.1 standard definition.CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to less than (<) 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.
Measured: From date of randomization until the date of first documented progression, assessed up to 48 months
Secondary outcomes (10)
Progression-Free Survival (PFS)
PFS was defined as the time from recruitment to the first occurrence of progressive disease(PD) or death due to any cause. PD: at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Overall survival (OS)
OS was defined as the time from the date of enrollment to the date of death due to any cause.
Measured: From date of randomization until the date of death from any cause, assessed up to 48 months
Compared the baseline sleep monitor results between Group NSCLC and Group OSA+NSCLC.
Record baseline AHI, oxygen desaturation index (ODI), lowest saturation by pulse oximetry (SpO2)<90%, obstructive apnea index (OAI), central apnea index(CAI), the longest apnea duration, then compare between Group NSCLC and Group OSA+NSCLC.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Factors associated with ORR in NSCLC patients
Cox regression analysis will be used to identify predictors of ORR.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Factors associated with OS and PFS in NSCLC patients
Univariate and multivariate Cox proportional hazards models will be used to identify predictors of PFS and OS.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Compared the baseline level of lymphocytes classification and count between Group NSCLC and Group OSA+NSCLC.
Record baseline lymphocytes classification and count in peripheral blood, then compare between Group NSCLC and Group OSA+NSCLC.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Compared the baseline level of inflammatory biomarkers between Group NSCLC and Group OSA+NSCLC.
Record baseline interleukin 6 (IL-6) and C-reactive Protein (CRP) in peripheral blood, then compare between Group NSCLC and Group OSA+NSCLC.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
The association between OSA and baseline inflammatory biomarkers, peripheral lymphocytes classification and count.
The Spearman correlation test will be used to identify the association between sleep monitor results and the baseline inflammatory biomarkers, peripheral lymphocytes classification and count, including AHI, ODI, lowest SpO2, SpO2<90%, OAI, CAI, the longest apnea duration
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Compared the baseline gut microbiome between Group NSCLC and Group OSA+NSCLC.
Record baseline gut microbiome by metagenomic shotgun sequencing, then compare between Group NSCLC and Group OSA+NSCLC.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
The association between OSA and the diversity of gut microbiome.
The Spearman correlation test will be used to identify the association between sleep monitor results and the diversity of gut microbiome, including AHI, ODI, lowest SpO2, SpO2<90%, OAI, CAI, the longest apnea duration.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start23 Feb 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing MA, Peking University First Hospital
- Investigators
- Jing Ma, MD, Study chair, Peking University First HospitalGuangfa Wang, MD, Study director, Peking University First HospitalYuan Cheng, Study director, Peking University First HospitalLigong Nie, Study director, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743752
- Sponsor's protocol ID
- 2020-405
- Status last verified
- Apr 2022
- First submitted
- 30 Jan 2021
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Influences Efficacy of Anti-Programmed-Death-1-Based Immunotherapy Against Non-Small Cell Lung Cancer - A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04743752
- Acronym / sponsor ID
- 2020-405
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Feb 2021 (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 prospective, observational cohort study aims to explore the influence of obstructive sleep apnea(OSA) on the efficacy of PD-1-based immunotherapy in patients with non-small cell lung cancer(NSCLC). Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited. According to sleep monitor results, participants will be divided into Group NSCLC and Group OSA+NSCLC. Primary outcome is the objective remission rate(ORR).
Detailed description
This is a single-center, prospective, observational cohort study. Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited and followed for 4 years. According to the baseline sleep monitor results, participants will be divided into Group NSCLC(AHI<15), and Group OSA+NSCLC(AHI≥15), and then explore the influence of obstructive sleep apnea on the efficacy of PD-1-based immunotherapy. The baseline level of white blood cell count (WBC); absolute neutrophil count (ANC); absolute lymphocyte count (ALC); ANC to ALC (ANC:ALC) ratio; interleukin 6 (IL-6); C-reactive Protein (CRP) in peripheral blood, lymphocytes classification and count by flow cytometry, and gut microbiome analysis by quantitative metagenomics will also be measured to further search for the possible mechanisms. Primary outcome is the objective remission rate (ORR), secondary outcomes include overall survival (OS) and progression free survival (PFS).
The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB). Any protocol modifications will be submitted for the IRB review and approval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group OSA+NSCLC | – | –According to the baseline sleep monitor results, participants will be divided into Group OSA+NSCLC if apnea hypopnea index(AHI) no less than 15. |
| Group NSCLC | – | –According to the baseline sleep monitor results, participants will be divided into Group NSCLC if apnea hypopnea index(AHI) less than 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited and followed for 4 years.
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed, advanced NSCLC
- Participants with no prior treatment for advanced NSCLC
- Measurable disease as defined by RECIST v1.1
- Eligible to receive first-line treatment including PD-1 antibody
- Adequate hematologic and end organ function
Key exclusion criteria (4 listed)
- Severe infection within 4 weeks prior to recruitment.
- Significant organ dysfunction or other serious diseases.
- Previous or current OSA related treatment, including oral appliance, surgery, mechanical ventilation therapy.
- Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective response rate(ORR)
Time frame: From date of randomization until the date of first documented progression, assessed up to 48 months
ORR, the percentage of complete response (CR) or partial response (PR) according to RECIST 1.1 standard definition.CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to less than (<) 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.
10 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 48 months
Compared the baseline sleep monitor results between Group NSCLC and Group OSA+NSCLC.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Factors associated with ORR in NSCLC patients
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Factors associated with OS and PFS in NSCLC patients
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Compared the baseline level of lymphocytes classification and count between Group NSCLC and Group OSA+NSCLC.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Compared the baseline level of inflammatory biomarkers between Group NSCLC and Group OSA+NSCLC.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
The association between OSA and baseline inflammatory biomarkers, peripheral lymphocytes classification and count.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Compared the baseline gut microbiome between Group NSCLC and Group OSA+NSCLC.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
The association between OSA and the diversity of gut microbiome.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- 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. This study is not recruiting at the moment.
Jing Ma, MD study chair
Peking University First Hospital
Guangfa Wang, MD study director
Peking University First Hospital
Yuan Cheng study director
Peking University First Hospital
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 Obstructive Sleep Apnea and Non-small Cell Lung Cancer, run by Peking University First Hospital 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Ma, MD (+8613651357974, majjmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: From date of randomization until the date of first documented progression, assessed up to 48 months). 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 26 Apr 2022.