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

NCT05477979 | Recruiting

• 1 other identifier: XYEYY20220704
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Psychological Stress; Immune Checkpoint Inhibitors; Cancer, Treatment-Related

Keywords

Lung cancer; Immune checkpoint inhibitors; Psychological stress; Cancer progression; Prognosis; Biomarker

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Overall survival (OS)

  5 years

• Quality of life

  5 years

• Objective Response Rate (ORR)

  2 years

Other Outcomes (3)

• The correlation between gut microbiota and chronic stress and the efficacy of ICIs

  5 years

• The correlation between tumor microenvironment signature and chronic stress and the efficacy of ICIs

  5 years

• The correlation between peripheral stress biomarker and immune cells signature and chronic stress and the efficacy of ICIs

  5 years

Study Arms (4)

Cohort 1: advanced NSCLC patients receiving first-line ICIs (STRESS-LUNG-1 study)

For stage IIIB-IV patients with NSCLC who have received immune checkpoint inhibitors as first-line therapy.

Other: Exposure: psychological stress status

Cohort 2: limited-stage and extensive-stage SCLC patients receiving ICIs (STRESS-LUNG-2 study)

For limited-stage and extensive-stage SCLC patients who have received immune checkpoint inhibitors

Other: Exposure: psychological stress status

Cohort 3: NSCLC patients receive neoadjuvant therapy of ICIs（STRESS-LUNG-3 study）

For stage IB-IIIB patients with non-small cell lung cancer who have received neoadjuvant therapy of immune checkpoint inhibitors.

Other: Exposure: psychological stress status

Cohort 4: NSCLC patients receive radical resection (STRESS-LUNG-4 study))

For early-stage patients with non-small cell lung cancer who have received radical resection.

Other: Exposure: psychological stress status

Interventions

Exposure: psychological stress status OTHER

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.

Cohort 1: advanced NSCLC patients receiving first-line ICIs (STRESS-LUNG-1 study); Cohort 2: limited-stage and extensive-stage SCLC patients receiving ICIs (STRESS-LUNG-2 study); Cohort 3: NSCLC patients receive neoadjuvant therapy of ICIs（STRESS-LUNG-3 study）; Cohort 4: NSCLC patients receive radical resection (STRESS-LUNG-4 study))

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

Department of Oncology, The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

RECRUITING

Related Publications (1)

• 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: 10.1038/s41591-024-02929-4. Epub 2024 May 13.

  PMID: 38740994 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Stress, Psychological; Neoplasms, Second Primary; Disease Progression

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fang Wu, MD. PhD

CONTACT

+86 13574858332; wufang4461@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2022
• First Posted: July 28, 2022
• Study Start: June 1, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)