Exploring how psychological stress affects lung cancer treatment outcomes

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)

This study is trying to see how psychological stress affects the success of immune treatments for different types of lung cancer patients.

Quick facts

• Study type: Observational
• Enrollment: 750 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Xiangya Hospital of Central South University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT05477979 on ClinicalTrials.gov

What this trial studies

This observational cohort study, known as STRESS-LUNG, aims to investigate the relationship between psychological stress and the effectiveness of immune checkpoint inhibitors (ICIs) in patients with lung cancer. It includes four distinct cohorts: patients with advanced non-small-cell lung cancer (NSCLC) receiving first-line ICIs, patients with small-cell lung cancer (SCLC) undergoing first-line ICIs, patients with resectable NSCLC receiving neoadjuvant ICIs, and early-stage NSCLC patients undergoing surgery. The study will assess how psychological stress impacts cancer progression and treatment efficacy, providing valuable insights into patient prognosis.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced NSCLC or SCLC who are receiving first-line therapy with immune checkpoint inhibitors.

Not a fit: Patients with concurrent acute or chronic psychiatric disorders or those with specific genetic mutations related to lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for lung cancer by addressing psychological stress as a factor in therapy efficacy.

How similar studies have performed: While the specific associations of psychological stress with lung cancer treatment outcomes are less explored, similar studies in other cancer types have shown promising results, indicating potential for success.

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;

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; Psychological Stress; Immune Checkpoint Inhibitors; Cancer, Treatment-Related; Lung cancer; Immune checkpoint inhibitors; Psychological stress; Cancer progression