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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Department of Oncology, The Second Xiangya Hospital, Central South University
RECRUITING
Changsha
Contact Information
Primary
Fang Wu, MD. PhD
wufang4461@csu.edu.cn
+86 13574858332
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 1270
Treatments
Advanced NSCLC patients receiving first-line ICIs
For stage IIIB-IV patients with NSCLC who have received immune checkpoint inhibitors as first-line therapy.
Limited-stage and extensive-stage SCLC patients receiving first-line ICIs
For limited-stage and extensive-stage SCLC patients who have received immune checkpoint inhibitors as first-line therapy.
NSCLC patients receiving neoadjuvant therapy of ICIs
For stage IB-IIIB patients with non-small cell lung cancer who have received neoadjuvant therapy of immune checkpoint inhibitors.
Early stage NSCLC patients receiving radical resection
For early-stage patients with non-small cell lung cancer who have received radical resection.
Advanced NSCLC patients receiving first-line targeted therapy
For stage IIIB-IV patients with NSCLC who have received targeted agents as first-line therapy.
Related Therapeutic Areas
Sponsors
Leads: Second Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov

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