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)

Overview

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.

Interventions

• 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.

Primary outcome measures

• Cohort 1 & 2: Progression-free survival (PFS) [Time frame: 3 years]
• Cohort 3: Pathologic complete response (pCR) rate [Time frame: 3 years]
• Cohort 4: Disease-free survival (DFS) [Time frame: 5 years]

Secondary outcome measures (3)

• Overall survival (OS) [Time frame: 5 years]
• Quality of life [Time frame: 5 years]
• Objective Response Rate (ORR) [Time frame: 2 years]

Eligibility criteria

Cohort 1 (STRESS-LUNG-1):

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；
• Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-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

• 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 3 (STRESS-LUNG-3):

• Age ≥18 years ；
• Pathologically diagnosed as non-small cell lung cancer;
• Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;
• At least one measurable lesion can be evaluated according to the RECIST 1.1 standard；
• Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
• 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

• 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;
• Can't cooperate with psychological scale assessment;

Cohort 4 (STRESS-LUNG-4):

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

Exclusion criteria

• 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;
• Can't cooperate with psychological scale assessment;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Department of Oncology, The Second Xiangya Hospital, Central South University — Changsha

Publications

• Zeng Y, Hu CH, Li YZ, Zhou JS, Wang SX, Liu MD, Qiu ZH, Deng C, Ma F, Xia CF, Liang F, Peng YR, Liang AX, Shi SH, Yao SJ, Liu JQ, Xiao WJ, Lin XQ, Tian XY, Zhang YZ, Tian ZY, Zou JA, Li YS, Xiao CY, Xu T, Zhang XJ, Wang XP, Liu XL, Wu F. Association between pretreatment emotional distress and immune checkpoint inhibitor response in non-small-cell lung cancer. Nat Med. 2024 Jun;30(6):1680-1688. doi PMID 38740994

Identifiers

NCT: NCT05477979 · XYEYY20220704

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗