Actively Recruiting
The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer
Led by Second Xiangya Hospital of Central South University · Updated on 2025-05-16
1270
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or pathologically confirmed diagnosis of NSCLC or SCLC
- Specific cancer stages as defined per cohort (advanced, locally advanced, metastatic, recurrent, or early stage)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 for applicable cohorts
- Treatment naive (no prior treatment)
- At least one measurable lesion according to RECIST v1.1 for applicable cohorts
- Receiving first-line therapy with immune checkpoint inhibitors, targeted therapy, or neoadjuvant therapy as per cohort
- Ability to undergo surgery for surgical cohorts
- Provision of informed consent to participate
- Availability of tumor tissue samples for early-stage surgical cohort
- Driver gene positive for targeted therapy cohort
You will not qualify if you...
- Presence of epidermal growth factor receptor (EGFR) mutation, ALK fusion, or ROS1 fusion for applicable cohorts
- Other malignant tumors or malignancies within the past 3 years
- Acute or chronic psychiatric disorders
- Current use of sleep medication
- Prior participation in other clinical drug trials
- Symptomatic brain metastases
- Inability to complete scale assessments or questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Oncology, The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011
Actively Recruiting
Research Team
F
Fang Wu, MD. PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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