NCT06975384 The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer
| NCT ID | NCT06975384 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Xiangya Hospital of Central South University |
| Condition | Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,270 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,270 participants in total. It began in 2024-11-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Cohort 1: Inclusion Criteria: 1. Age ≥ 18 years old; 2. Histologically confirmed diagnosis of NSCLC; 3. Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1; 5. Treatment naïve; 6. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1); 7. Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy; 8. Informed consent to participate in the study; Exclusion Criteria: 1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) fusion and/or ROS proto-oncogene 1 (ROS1) fusion-positive; 2. Presence of other malignant tumors or malignant diseases within 3 years; 3. Concurrent acute or chronic psychiatric disorders; 4. Patients receiving sleep medication; 5. Prior participation in other clinical drug trials; 6. Symptomatic brain metastasis; 7. Inability to complete scale assessments. Cohort 2: Inclusion Criteria: 1. Age ≥ 18 years old; 2. Histologically confirmed diagnosis of SCLC； 3. Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition; 4. ECOG PS of 0-1; 5. Treatment naïve; 6. Presence of at least one measurable lesion according to the RECIST v1.1 ; 7. Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy; 8. Informed consent to participate in the study; Exclusion Criteria: 1. Presence of other malignant tumors or malignant diseases within 3 years; 2. Concurrent acute or chronic psychiatric disorders; 3. Patients receiving sleep medication; 4. Prior participation in other clinical drug trials; 5. Symptomatic brain metastasis; 6. Inability to complete scale assessments. Cohort 3: Inclusion Criteria: 1. Age ≥18 years old; 2. Pathologically diagnosed as NSCLC; 3. Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition; 4. At least one measurable lesion can be evaluated according to the RECIST v1.1; 5. Treatment naïve; 6. Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy as neoadjuvant therapy; 7. Cardiopulmonary function can withstand surgery; 8. Informed consent to participate in the study. Exclusion Criteria: 1. EGFR-sensitizing mutation and/or ALK fusion and/or ROS1 fusion-positive; 2. Presence of other malignant tumors or malignant diseases within 3 years; 3. Concurrent acute or chronic psychiatric disorders; 4. Patients receiving sleep medication; 5. Prior participation in other clinical drug trials; 6. Symptomatic brain metastasis; 7. Inability to complete scale assessments. Cohort 4: Inclusion Criteria: 1. Age ≥ 18 years old; 2. Pathologically diagnosed as NSCLC; 3. Pathologically stage confirmed as early stage of IA-IIIA; 4. Available for tumor tissue samples; 5. Treatment naïve; 6. Receiving radical surgery; 7. Informed consent to participate in the study; Exclusion Criteria: 1. Presence of other malignant tumors or malignant diseases within 3 years; 2. Concurrent acute or chronic psychiatric disorders; 3. Patients receiving sleep medication; 4. Prior participation in other clinical drug trials; 5. Inability to complete scale assessments. Cohort 5: Inclusion Criteria: 1. Age ≥ 18 years old; 2. Histologically confirmed diagnosis of NSCLC; 3. Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition; 4. ECOG PS of 0-1; 5. Treatment naive; 6. Presence of at least one measurable lesion according to the RECIST v1.1; 7. Receiving targeted therapy or combination with chemotherapy; 8. Informed consent to participate in the study; 9. Driver gene-positive. Exclusion Criteria: 1. Presence of other malignant tumors or malignant diseases within 3 years; 2. Concurrent acute or chronic psychiatric disorders; 3. Patients receiving sleep medication; 4. Prior participation in other clinical drug trials; 5. Symptomatic brain metastasis; 6. Inability to complete scale assessments.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06975384 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06975384 currently recruiting?
Yes, NCT06975384 is actively recruiting participants. Contact the research team at wufang4461@csu.edu.cn for enrollment information.
Where is the NCT06975384 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06975384 clinical trial?
NCT06975384 is sponsored by Second Xiangya Hospital of Central South University. The trial plans to enroll 1,270 participants.
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