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)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Department of Oncology, The Second Xiangya Hospital, Central South University
RECRUITING
Changsha
Contact Information
Primary
Fang Wu, MD. PhD
wufang4461@csu.edu.cn
+86 13574858332
Time Frame
Start Date: 2020-06-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 750
Treatments
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.
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
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Second Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov