Non-small Cell Lung Cancer(NSCLC)NCT06757114
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
An observational study of Non-small Cell Lung Cancer(NSCLC), run by Second Affiliated Hospital of Xi'an Jiaotong University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer(NSCLC)
- What is being tested?
- High altitude
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with advanced non-small cell lung cancer receiving first-line immunotherapy at high and low altitudes
Who may be able to join
- (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;
Who cannot join
- 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;
- Prior immunosuppressive therapy prior to exclusion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study on the Multi-omic Factors Influencing the Efficacy of Immunotherapy and Adverse Reactions of Immunotherapy in Patients with Primary Non-small Cell Lung Cancer in High-altitude Areas
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)
- Being tested
- High altitude
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High altitudeOther
High altitude is defined as a long-term residence with an altitude of 1500m and above
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Type and severity of immune-related adverse effects
Measured: 2024/10/1-2025/3/31:Data Collection；2025/4/1-2025/6/3:Preliminary analysis；
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer(NSCLC)Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757114
- Sponsor's protocol ID
- （2024）EC-KY（NO.076）
- Status last verified
- Sep 2024
- First submitted
- 10 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Multi-omic Factors Influencing the Efficacy of Immunotherapy and Adverse Reactions of Immunotherapy in Patients with Primary Non-small Cell Lung Cancer in High-altitude Areas
- ClinicalTrials.gov ID
- NCT06757114
- Acronym / sponsor ID
- （2024）EC-KY（NO.076）
- Conditions
- Non-small Cell Lung Cancer(NSCLC)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 3 Jan 2025 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced non-small cell lung cancer receiving first-line immunotherapy at high and low altitudes
Key inclusion criteria (1 listed)
- (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;
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| High altitudeHigh altitude is defined as a long-term residence with an altitude of 1500m and above | Other | – |
Primary outcome
Efficacy of first-line immunotherapy for advanced non-small cell lung cancer at high and low altitudes
Time frame: 2024/10/1-2025/3/31:Data Collection；2025/4/1-2025/6/3:Preliminary analysis；
The evaluation indicators included progression-free survival(PFS), overall survival(OS), objective response rate(ORR), and disease conrtol rate(DCR)
1 secondary outcome
Immune-related adverse reactions in patients with non-small cell lung cancer receiving first-line immunotherapy at high and low altitudes
Time frame: 2024/10/1-2025/3/31:Data Collection；2025/4/1-2025/6/3:Preliminary analysis；
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer(NSCLC), run by Second Affiliated Hospital of Xi'an Jiaotong University.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Guo, Doctor (8613572824106, guohui@xjtufh.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of first-line immunotherapy for advanced non-small cell lung cancer at high and low altitudes (time frame: 2024/10/1-2025/3/31:Data Collection；2025/4/1-2025/6/3:Preliminary analysis；). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2025.