Clinical trial · Observational
Obstructive Sleep Apnea Influences Efficacy of PD-1-Based Immunotherapy Against Non-Small Cell Lung Cancer
Obstructive Sleep Apnea Influences Efficacy of Anti-Programmed-Death-1-Based Immunotherapy Against Non-Small Cell Lung Cancer - A Prospective Observational Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Obstructive Sleep Apnea | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Group OSA+NSCLC
- description
- According to the baseline sleep monitor results, participants will be divided into Group OSA+NSCLC if apnea hypopnea index(AHI) no less than 15.
- label
- Group NSCLC
- description
- According to the baseline sleep monitor results, participants will be divided into Group NSCLC if apnea hypopnea index(AHI) less than 15.
Primary outcomes (1)
- measure
- Objective response rate(ORR)
- timeFrame
- From date of randomization until the date of first documented progression, assessed up to 48 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed, advanced NSCLC 2. Participants with no prior treatment for advanced NSCLC 3. Measurable disease as defined by RECIST v1.1 4. Eligible to receive first-line treatment including PD-1 antibody 5. Adequate hematologic and end organ function Exclusion Criteria: 1. Severe infection within 4 weeks prior to recruitment. 2. Significant organ dysfunction or other serious diseases. 3. Previous or current OSA related treatment, including oral appliance, surgery, mechanical ventilation therapy. 4. Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.
References
Publications (0)
Data not yet available