NCT05477979 The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG)
| NCT ID | NCT05477979 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Xiangya Hospital of Central South University |
| Condition | Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 750 participants |
| Start Date | 2020-06-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 750 participants in total. It began in 2020-06-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Cohort 1 (STRESS-LUNG-1): Inclusion Criteria: 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; 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. 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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05477979 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05477979 currently recruiting?
Yes, NCT05477979 is actively recruiting participants. Contact the research team at wufang4461@csu.edu.cn for enrollment information.
Where is the NCT05477979 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT05477979 clinical trial?
NCT05477979 is sponsored by Second Xiangya Hospital of Central South University. The trial plans to enroll 750 participants.
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