Lung CancerNCT05477979
The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG)
An observational study of Lung Cancer and Psychological Stress, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Psychological Stress, Immune Checkpoint Inhibitors
- What is being tested?
- Exposure: psychological stress status
- Type of treatment
- Injection or infusion
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 31 Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
- 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;
- 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;
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Oncology, The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011
Fang Wu, MD, PhD, +86 13574858332, wufang4461@csu.edu.cn
About this study
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)
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.
Read the 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.
- Conditions
- Lung Cancer, Psychological Stress, Immune Checkpoint Inhibitors, Cancer, Treatment-Related
- Being tested
- Exposure: psychological stress status
- Keywords
- Lung cancer, Immune checkpoint inhibitors, Psychological stress, Cancer progression, Prognosis, Biomarker
- Medical subject headings
- Lung Neoplasms, Stress, Psychological, Neoplasms, Second Primary, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure: psychological stress statusOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: 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. Receives: Other: Exposure: psychological stress status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3 years
Cohort 4: Disease-free survival (DFS)
The duration between the date after surgery to the date of any recurrence or death firstly
Measured: 5 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Jun 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Wu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477979
- Sponsor's protocol ID
- XYEYY20220704
- Status last verified
- Feb 2025
- First submitted
- 23 Jul 2022
- Last updated
- 25 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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: 10.1038/s41591-024-02929-4. Epub 2024 May 13.
PubMed 38740994
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05477979
- Acronym / sponsor ID
- XYEYY20220704
- Conditions
- Lung Cancer, Psychological Stress, Immune Checkpoint Inhibitors, Cancer, Treatment-Related
- Keywords
- Lung cancer, Immune checkpoint inhibitors, Psychological stress, Cancer progression, Prognosis, Biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: advanced NSCLC patients receiving first-line ICIs (STRESS-LUNG-1 study) | – | Other: Exposure: psychological stress statusFor stage IIIB-IV patients with NSCLC who have received immune checkpoint inhibitors as first-line therapy. |
| Cohort 2: limited-stage and extensive-stage SCLC patients receiving ICIs (STRESS-LUNG-2 study) | – | Other: Exposure: psychological stress statusFor limited-stage and extensive-stage SCLC patients who have received immune checkpoint inhibitors |
| Cohort 3: NSCLC patients receive neoadjuvant therapy of ICIs（STRESS-LUNG-3 study） | – | Other: Exposure: psychological stress statusFor stage IB-IIIB patients with non-small cell lung cancer who have received neoadjuvant therapy of immune checkpoint inhibitors. |
| Cohort 4: NSCLC patients receive radical resection (STRESS-LUNG-4 study)) | – | Other: Exposure: psychological stress statusFor early-stage patients with non-small cell lung cancer who have received radical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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 );
Key exclusion criteria (49 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure: psychological stress statusThe 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. | Other | 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)) |
Primary outcome
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 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.
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
3 secondary outcomes
Overall survival (OS)
Time frame: 5 years
Quality of life
Time frame: 5 years
Objective Response Rate (ORR)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Derived from this study: PubMed 38740994Zeng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Psychological Stress, run by Second Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Wu, MD. PhD (+86 13574858332, wufang4461@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1 & 2: Progression-free survival (PFS) (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05477979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.