A Study on the Efficacy of Immunotherapy, the Occurrence and Severity of Adverse Reactions in Patients with Non-small Cell Lung Cancer in High-altitude Areas

NCT06757114 | Not Yet Recruiting DMC

• 1 other identifier: （2024）EC-KY（NO.076）
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

As a major disease with high incidence and mortality rate, lung cancer seriously threatens the health of our people and causes a huge burden of disease. In recent years, with the widespread use of immune checkpoint inhibitors (ICIs), great progress has been made in the treatment of lung cancer, which has brought significant survival benefits to patients. Although ICI has greatly improved the prognosis of lung cancer patients, due to the complexity of the mechanism of action of ICI and the heterogeneity within the tumor, the benefit population of treatment is relatively limited, and some patients are still at risk of primary drug resistance and tumor hyperprogression.In this study, we aimed to compare the differences in the efficacy and adverse reactions of immunotherapy in patients with advanced non-small cell lung cancer at high and low altitudes, and to find out the relevant factors from multiple omics such as imaging, pathology, and genetics, so as to solve the problem of immunotherapy resistance

Conditions

Non-small Cell Lung Cancer(NSCLC)

Outcome Measures

Primary Outcomes (1)

• Efficacy of first-line immunotherapy for advanced non-small cell lung cancer at high and low altitudes

  The evaluation indicators included progression-free survival(PFS), overall survival(OS), objective response rate(ORR), and disease conrtol rate(DCR)

  2024/10/1-2025/3/31:Data Collection；2025/4/1-2025/6/3:Preliminary analysis；

Secondary Outcomes (1)

• Immune-related adverse reactions in patients with non-small cell lung cancer receiving first-line immunotherapy at high and low altitudes

  2024/10/1-2025/3/31:Data Collection；2025/4/1-2025/6/3:Preliminary analysis；

Interventions

High altitude OTHER

High altitude is defined as a long-term residence with an altitude of 1500m and above

Eligibility Criteria

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

Study Population

Patients with advanced non-small cell lung cancer receiving first-line immunotherapy at high and low altitudes

You may qualify if:

• (1) Patients with primary non-small cell lung cancer (adenocarcinoma/squamous cell carcinoma/adenosquamous cell carcinoma/large cell lung cancer/others) with clear cellular/histopathological evidence; (2) Primary non-small cell lung cancer of any stage receiving immunotherapy for the first time; (3) Patients who have undergone at least 2 cycles of immunotherapy during the treatment period and have undergone one efficacy evaluation; (4) Patients with at least one evaluable target lesion (except for those with uncontrolled brain metastases) according to Response Evaluation Criteria for Solid T Tumors (RECIST, version 1.1); (5) Voluntary participation in research and strong willingness to cooperate; (6) has been residing in Qinghai Province since birth; (7) Have been residing in Shaanxi Province since birth; (8) Be at least 18 years old;

You may not qualify if:

• Patients with unknown histopathological type were excluded;
• Patients with unclear diagnosis and treatment information and immunotherapy-related adverse reactions;
• Patients with bipolar/multiple primary non-small cell lung cancer with other tumors were excluded;
• Patients who are unwilling to join the study and have poor willingness to cooperate;
• Patients who migrated to Qinghai or Shaanxi from different altitudes and had a history of migration between the two provinces were excluded;
• exclude patients with a history of emigration from parents;
• Patients who have received immunotherapy for other tumors in the past;

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Hui Guo, Doctor

CONTACT

8613572824106; guohui@xjtufh.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: January 3, 2025
• Study Start: January 1, 2025
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share