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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Second Xiangya Hospital of Central South University
- Enrollment
- 750
- Locations
- 1
- Primary Endpoint
- Cohort 1 & 2: Progression-free survival (PFS)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Fang Wu
Professor
Central South University
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years;
- •Histologically confirmed diagnosis of NSCLC;
- •Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
- •Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;
- •Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
- •Informed and agreed to participate in the study;
Exclusion Criteria
- •Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) gene and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
- •Combined with other malignant tumors in the past 3 years;
- •Concurrent acute or chronic psychiatric disorders;
- •Current receiving anti-depressive or anti-anxiety therapy;
- •Previous treatment with other clinical drug trials;
- •Patients with symptomatic brain metastasis;
- •Can't cooperate with psychological scale assessment;
- •Cohort 2 (STRESS-LUNG-2):
- •Age ≥ 18 years；
- •Pathologically diagnosed as small cell lung cancer；
Outcomes
Primary Outcomes
Cohort 1 & 2: Progression-free survival (PFS)
Time Frame: 3 years
Time from the beginning of first-line immunotherapy to the first progression (PD) in patients with lung cancer
Cohort 4: Disease-free survival (DFS)
Time Frame: 5 years
The duration between the date after surgery to the date of any recurrence or death firstly
Cohort 3: Pathologic complete response (pCR) rate
Time Frame: 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.
Secondary Outcomes
- Quality of life(5 years)
- Objective Response Rate (ORR)(2 years)
- Overall survival (OS)(5 years)