NCT06975384Recruiting

The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer

The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging

Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Observational
Enrollment: 1270 (estimated)
First submitted: 9 May 2025
Start date: 1 Nov 2024
Primary completion date: 31 Dec 2029
Lead sponsor: Second Xiangya Hospital of Central South University
Diseases: Lung cancer
NCT number: NCT06975384

What you commit to

Study type: Observational
Planned participants: 1270
From 1 Nov 2024 to the primary completion date, 31 Dec 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Concurrent acute or chronic psychiatric disorders;
Patients receiving sleep medication;
Prior participation in other clinical drug trials;
Concurrent acute or chronic psychiatric disorders;
Patients receiving sleep medication;
Prior participation in other clinical drug trials;
Concurrent acute or chronic psychiatric disorders;
Patients receiving sleep medication;
Prior participation in other clinical drug trials;
Concurrent acute or chronic psychiatric disorders;
Patients receiving sleep medication;
Prior participation in other clinical drug trials;
Concurrent acute or chronic psychiatric disorders;
Patients receiving sleep medication;
Prior participation in other clinical drug trials;

Other illness

Presence of other malignant tumors or malignant diseases within 3 years;
Presence of other malignant tumors or malignant diseases within 3 years;
Presence of other malignant tumors or malignant diseases within 3 years;
Presence of other malignant tumors or malignant diseases within 3 years;
Presence of other malignant tumors or malignant diseases within 3 years;

Lab values

Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) fusion and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
EGFR-sensitizing mutation and/or ALK fusion and/or ROS1 fusion-positive;

Other

Symptomatic brain metastasis;
Inability to complete scale assessments.
- Cohort 2:
Symptomatic brain metastasis;
Inability to complete scale assessments.
- Cohort 3:
Symptomatic brain metastasis;
Inability to complete scale assessments.
- Cohort 4:
Inability to complete scale assessments.
- Cohort 5:
Symptomatic brain metastasis;
Inability to complete scale assessments.

Who the study is looking for

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;
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;
Age ≥18 years old;
Pathologically diagnosed as NSCLC;
Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;
At least one measurable lesion can be evaluated according to the RECIST v1.1;
Treatment naïve;
Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy as neoadjuvant therapy;
Cardiopulmonary function can withstand surgery;
Informed consent to participate in the study.
Age ≥ 18 years old;
Pathologically diagnosed as NSCLC;
Pathologically stage confirmed as early stage of IA-IIIA;
Available for tumor tissue samples;
Treatment naïve;
Receiving radical surgery;
Informed consent to participate in the study;
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;
ECOG PS of 0-1;
Treatment naive;
Presence of at least one measurable lesion according to the RECIST v1.1;
Receiving targeted therapy or combination with chemotherapy;
Informed consent to participate in the study;
Driver gene-positive.

Criteria the registry did not label

Cohort 1:

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Department of Oncology, The Second Xiangya Hospital, Central South University Coordinator of this site? Confirm its status	Changsha	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.