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Recruiting Observational

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

NCT05477979 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2020-06-01
Last updated
2025-02-25

Condition(s) studied

Lung CancerPsychological StressImmune Checkpoint InhibitorsCancer, Treatment-Related

Investigational drug(s) / intervention(s)

Exposure: psychological stress status

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Cohort 1 & 2: Progression-free survival (PFS) — 3 years
    Time from the beginning of first-line immunotherapy to the first progression (PD) in patients with lung cancer
  • Cohort 3: Pathologic complete response (pCR) rate — 3 years
    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.
  • Cohort 4: Disease-free survival (DFS) — 5 years
    The duration between the date after surgery to the date of any recurrence or death firstly

Trial sites (1)

FacilityCityRegionStatus
Department of Oncology, The Second Xiangya Hospital, Central South University Changsha Hunan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05477979 on ClinicalTrials.gov ↗ ← All trials in China