Clinical trial NCT05477979: The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG)
Official title: Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging (STRESS-LUNG)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Psychological Stress
Immune Checkpoint Inhibitors
Cancer, Treatment-Related
Keywords: Lung cancer
Immune checkpoint inhibitors
Psychological stress
Cancer progression
Prognosis
Biomarker
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received the first-line therapy or neoadjuvant therapy of ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early small-cell lung cancer (SCLC) receiving surgery.

Brief summary: This is the prospective, observational cohort study (STRESS-LUNG) to explore the associations of psychological stress 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 the first-line therapy or neoadjuvant therapy of ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early small-cell lung cancer (SCLC) receiving surgery.

Detailed description: This is the prospective, observational cohort study (STRESS-LUNG) to explore the associations of psychological stress with progression, efficacy of ICIs and prognosis of Lung Cancer. This study will have 4 cohorts

* Cohort 1 (STRESS-LUNG-1): A prospective, observational cohort study to explore the association between psychological stress and the efficacy of first-line treatment of ICIs in advanced NSCLC.
* Cohort 2 (STRESS-LUNG-2): A prospective, observational cohort study to explore the association between psychological stress and the efficacy of first-line treatment of limited-stage and extensive-stage SCLC.
* Cohort 3 (STRESS-LUNG-3): A prospective, observational cohort study to explore the association between psychological stress and the efficacy of neoadjuvant therapy of ICIs in resectable NSCLC.
* Cohort 4 (STRESS-LUNG-4): A prospective, observational cohort study to explore the association of psychological stress with cancer progression, and Prognosis in early-stage NSCLC receiving radical surgery.

Eligibility criteria: Cohort 1 (STRESS-LUNG-1):

Inclusion Criteria:

1. Age ≥ 18 years;
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 of 0-1;
5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
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 and agreed to participate in the study;

Exclusion Criteria:

1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) gene and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
2. Combined with other malignant tumors in the past 3 years;
3. Concurrent acute or chronic psychiatric disorders;
4. Current receiving anti-depressive or anti-anxiety therapy;
5. Previous treatment with other clinical drug trials;
6. Patients with symptomatic brain metastasis;
7. Can't cooperate with psychological scale assessment;

Cohort 2 (STRESS-LUNG-2):

1. Age ≥ 18 years；
2. Pathologically diagnosed as small cell lung cancer；
3. Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
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 and agreed to participate in the study;

Exclusion Criteria:

1. Combined with other malignant tumors in the past 3 years;
2. Concurrent acute or chronic psychiatric disorders;
3. Current receiving anti-depressive or anti-anxiety therapy;
4. Previous treatment with other clinical drug trials;
5. Patients with symptomatic brain metastasis;
6. Can't cooperate with psychological scale assessment;

Cohort 3 (STRESS-LUNG-3):

1. Age ≥18 years ；
2. Pathologically diagnosed as non-small cell lung cancer;
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 1.1 standard；
5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
6. Receiving PD-1/PD-L1 inhibitors combined with chemotherapy as neoadjuvant therapy.

6. Cardiopulmonary function can withstand surgery; 7. Informed and agreed to participate in the study;

Exclusion Criteria:

1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) gene and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
2. Combined with other malignant tumors in the past 3 years;
3. Concurrent acute or chronic psychiatric disorders;
4. Current receiving anti-depressive or anti-anxiety therapy;
5. Previous treatment with other clinical drug trials;
6. Can't cooperate with psychological scale assessment;

Cohort 4 (STRESS-LUNG-4):

1. Age ≥18 years;
2. Pathologically diagnosed as non-small-cell lung cancer；
3. Pathologically stage conformed as early stage of IA-IIIA
4. Available for tumor tissue samples；
5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
6. Receiving radical surgery;
7. Informed and agreed to participate in the study;

Exclusion Criteria:

1. Combined with other malignant tumors in the past 3 years;
2. Concurrent acute or chronic psychiatric disorders;
3. Current receiving anti-depressive or anti-anxiety therapy;
4. Previous treatment with other clinical drug trials;
5. Can't cooperate with psychological scale assessment;

Primary outcomes:
measure: Cohort 1 & 2: Progression-free survival (PFS)
timeFrame: 3 years
measure: Cohort 3: Pathologic complete response (pCR) rate
timeFrame: 3 years
measure: Cohort 4: Disease-free survival (DFS)
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
measure: Quality of life
timeFrame: 5 years
measure: Objective Response Rate (ORR)
timeFrame: 2 years
Other outcomes:
measure: The correlation between gut microbiota and chronic stress and the efficacy of ICIs
timeFrame: 5 years
measure: The correlation between tumor microenvironment signature and chronic stress and the efficacy of ICIs
timeFrame: 5 years
measure: The correlation between peripheral stress biomarker and immune cells signature and chronic stress and the efficacy of ICIs
timeFrame: 5 years
Locations:
city: Changsha
country: China
facility: Department of Oncology, The Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
References: