Exploring how sleep disturbances affect lung cancer treatment outcomes

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

This study is trying to see how sleep problems affect the success of immune treatments in people with lung cancer.

Quick facts

• Study type: Observational
• Enrollment: 1270 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Xiangya Hospital of Central South University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06975384 on ClinicalTrials.gov

What this trial studies

This observational cohort study aims to investigate the relationship between sleep disturbances and the efficacy of immune checkpoint inhibitors (ICIs) in patients with lung cancer. It includes five cohorts focusing on different patient groups, such as those with advanced non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC), as well as patients undergoing surgery for early-stage NSCLC. The study will assess how sleep quality impacts cancer progression and treatment outcomes, providing valuable insights into patient prognosis. Participants will be monitored for their sleep disturbance status and treatment responses over time.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced or early-stage lung cancer who are receiving specific therapies.

Not a fit: Patients with certain genetic mutations or those with concurrent psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for lung cancer patients by addressing sleep disturbances.

How similar studies have performed: While the specific associations of sleep disturbances with lung cancer treatment outcomes are less explored, similar studies in other cancer types have shown promising results.

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.

Where this trial is running

Changsha, Hunan

• Department of Oncology, The Second Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Fang Wu, MD. PhD

Conditions Lung Cancer; Sleep Disturbance; Immune Checkpoint Inhibitors; Cancer, Treatment-Related; Circadian Rhythm; Cancer Progression; Prognosis; Biomarker