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Clinical Trial NCT05477979 for Lung Cancer, Psychological Stress, Immune Checkpoint Inhibitors, Cancer, Treatment-Related is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG) 750 Observational

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Clinical Trial NCT05477979 is an observational study for Lung Cancer, Psychological Stress, Immune Checkpoint Inhibitors, Cancer, Treatment-Related that is recruiting. It started on 1 June 2020 with plans to enroll 750 participants. Led by Second Xiangya Hospital of Central South University, it is expected to complete by 31 December 2028. The latest data from ClinicalTrials.gov was last updated on 25 February 2025.
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-...Show More
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 ...
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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)

Conditions
Lung CancerPsychological StressImmune Checkpoint InhibitorsCancer, Treatment-Related
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • XYEYY20220704
NCT ID Number
NCT05477979
Start Date (Actual)
2020-06-01
Last Update Posted
2025-02-25
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
750
Study Type
Observational
Status
Recruiting
Keywords
Lung cancer
Immune checkpoint inhibitors
Psychological stress
Cancer progression
Prognosis
Biomarker
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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.
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.
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
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.
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.
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.
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.
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
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Overall survival (OS)
Overall survival (OS) is defined as the duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.
5 years
Quality of life
Quality of life (QoL) is assessed longitude by Short Form Health Survey 36 (SF-36) and EORTC QLQ-C30 (version.3). SF-36 includes 36 items and assesses the functional status and well-being on eight multi-item subscales. The total score on each SF-36 subscale ranges between 0 and 100. A greater score indicates better QoL. The EORTC QLQ-C30 is composed of 9 multi-item scales: 5 functioning scales (physical, role, cognitive, emotional, and social), a global QOL scale, and 3 symptom scales (fatigue, pain, and nausea/vomiting). All scales and single items are linearly transformed to an 0-100 scale. A higher score represents a better level of functioning.
5 years
Objective Response Rate (ORR)
The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
2 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Cohort 1 (STRESS-LUNG-1):
  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;

  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;
Second Xiangya Hospital of Central South University logoSecond Xiangya Hospital of Central South University
Study Responsible Party
Fang Wu, Principal Investigator, Professor, Central South University
Study Central Contact
Contact: Fang Wu, MD. PhD, +86 13574858332, [email protected]
1 Study Locations in 1 Countries

Hunan

Department of Oncology, The Second Xiangya Hospital, Central South University, Changsha, Hunan, 410011, China
Fang Wu, MD, PhD, Contact, +86 13574858332, [email protected]
Recruiting