Status:
RECRUITING
The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer
Lead Sponsor:
Second Xiangya Hospital of Central South University
Conditions:
Lung Cancer
Sleep Disturbance
Eligibility:
All Genders
18+ years
Brief Summary
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 Can...
Detailed Description
This is the prospective, observational cohort study (Nezha) to explore the associations of sleep disturbance with progression, efficacy of ICIs and prognosis of Lung Cancer. This study will have 5 coh...
Eligibility Criteria
Inclusion
- Cohort 1:
- 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;
Exclusion
- 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;
Key Trial Info
Start Date :
November 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
1270 Patients enrolled
Trial Details
Trial ID
NCT06975384
Start Date
November 1 2024
End Date
December 31 2030
Last Update
May 16 2025
Active Locations (1)
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1
Department of Oncology, The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011