The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer
Recruiting now
Conditions studied: Lung Cancer, Sleep Disturbance, Immune Checkpoint Inhibitors, Cancer, Treatment-Related
In brief
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.
Key facts
- Study ID
- NCT06975384
- Run by
- Second Xiangya Hospital of Central South University
- People needed
- 1270
- Starts
- 2024-11-01
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2025-05-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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);
- Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
- Informed consent to participate in the study;
You may not qualify if…
- 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;
- Inability to complete scale assessments.
- Cohort 2:
- Inclusion Criteria:
- 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;
- Exclusion Criteria:
- 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:
Where it is running
- Department of Oncology, The Second Xiangya Hospital, Central South University — Changsha, Hunan, China (enrolling)
Full record on ClinicalTrials.gov
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