The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG)

Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05477979
• Other study ID #: XYEYY20220704
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Second Xiangya Hospital of Central South University
• Contact: Fang Wu, MD. PhD
• Phone: +86 13574858332
• Email: wufang4461[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?B-? 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 ?-? 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;

Related Conditions & MeSH terms

• Cancer, Treatment-Related
• Immune Checkpoint Inhibitors
• Lung Cancer
• Lung Neoplasms
• Neoplasms, Second Primary
• Psychological Stress
• Stress, Psychological

Intervention

Other:
• Exposure: psychological stress status
The assessment of depressive and anxiety symptoms was conducted using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment 7 (GAD-7). Patients with a PHQ-9 score = 5 or a GAD-7 score = 5 were categorized as the stressed group.

Locations

Country	Name	City	State
China	Department of Oncology, The Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The correlation between gut microbiota and chronic stress and the efficacy of ICIs	The baseline fetal is collected and assessed by 16S rRNA sequencing. And explore the association between gut microbiota and chronic stress and the efficacy of ICIs during the enrolled observation process.	5 years
Other	The correlation between tumor microenvironment signature and chronic stress and the efficacy of ICIs	The baseline paraffin-embedded tissue is collected and assessed by multiplex immunohistochemistry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and DC cells. And explore the association between tumor microenvironment signature and chronic stress and the efficacy of ICIs during the enrolled observation process.	5 years
Other	The correlation between peripheral stress biomarker and immune cells signature and chronic stress and the efficacy of ICIs	The baseline peripheral venous blood is collected. The stress biomarkers including epinephrine, norepinephrine, cortisol and ACTH. The peripheral immune cells signature and assessed by flow cytometry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and DC cells.	5 years
Primary	Cohort 1 & 2: Progression-free survival (PFS)	Time from the beginning of first-line immunotherapy to the first progression (PD) in patients with lung cancer	3 years
Primary	Cohort 3: Pathologic complete response (pCR) rate	pCR is no viable tumor cells in tumor bed and lymph nodes. The pCR rate is the proportion of patients with a pathologic complete response.	3 years
Primary	Cohort 4: Disease-free survival (DFS)	The duration between the date after surgery to the date of any recurrence or death firstly	5 years
Secondary	Overall survival (OS)	Overall survival (OS) is defined as the duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.	5 years
Secondary	Quality of life	Quality of life (QoL) is assessed longitude by Short Form Health Survey 36 (SF-36) and EORTC QLQ-C30 (version.3).; SF-36 includes 36 items and assesses the functional status and well-being on eight multi-item subscales. The total score on each SF-36 subscale ranges between 0 and 100. A greater score indicates better QoL.; The EORTC QLQ-C30 is composed of 9 multi-item scales: 5 functioning scales (physical, role, cognitive, emotional, and social), a global QOL scale, and 3 symptom scales (fatigue, pain, and nausea/vomiting). All scales and single items are linearly transformed to an 0-100 scale. A higher score represents a better level of functioning.	5 years
Secondary	Objective Response Rate (ORR)	The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)	2 years