lung cancer
Conditions
Interventions
Cohort 1: Advanced NSCLC patients receiving first-line ICIs:None
Cohort 2: Limited-stage and extensive-stage SCLC patients receiving first-line ICIs:None
Cohort 3: NSCLC patients receiving neoadjuvant therapy of ICIs:None
Cohort 4: Early stage NSCLC patients receiving radical resection:None
Cohort 5: Advanced NSCLC patients receiving first-line targeted therapy:None
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Cohort 1: Inclusion Criteria: 1. Age >= 18 years old; 2. Histologically confirmed diagnosis of NSCLC; 3. Unresectable locally advanced, metastatic, or recurrent stage ?B-? 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; Cohort 2: Inclusion Criteria: 1. Age >= 18 years old; 2. Histologically confirmed diagnosis of SCLC; 3. Unresectable locally advanced, metastatic, or recurrent stage ?-? 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; 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. 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; Cohort 5: Inclusion Criteria: 1. Age >= 18 years old; 2. Histologically confirmed diagnosis of NSCLC; 3. Unresectable locally advanced, metastatic, or recurrent stage ?B-? 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
Exclusion criteria: Cohort 1: 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: 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: 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: 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Event-free survival;Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life;Objective Response Rate;Pathologic complete response (pCR) rate;Major pathologic response;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactWu Fang
The Second Xiangya Hospital of Central South University
Outcome results
None listed