LUNG CANCERNCT07142057
An Observational Study on the Impact of the 23-valent Pneumonia Vaccine on Lung Cancer Patients
An observational study of LUNG CANCER, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial summary
To evaluate the impact of the 23-valent pneumonia vaccine on the incidence of pulmonary infection and survival in lung cancer patients, and to explore its preventive effect and safety in the lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LUNG CANCER
- What is being tested?
- 23-valent pneumococcal vaccine
- Type of treatment
- Vaccines
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2030
- 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: Lung cancer patients can receive or not receive the 23-valent pneumococcal vaccine
Who may be able to join
- Male or female patients >=18 years of age;
- Histological diagnosis of NSCLC, including both non-small cell lung cancer and small cell lung cancer, regardless of whether they are in the early, locally advanced stage or advanced stage, and regardless of whether they have received surgery, radiotherapy, chemotherapy or other treatments;
- Never received pneumococcal vaccine
Who cannot join
- Patients having other factors that preventing researchers from enrollment them.
About this study
Official title: An Observational Study on the Impact of the 23-valent Pneumonia Vaccine on the Incidence of Pulmonary Infection and Survival in Lung Cancer Patients
To evaluate the impact of the 23-valent pneumonia vaccine on the incidence of pulmonary infection and survival in lung cancer patients, and to explore its preventive effect and safety in the lung cancer patients.
- Conditions
- LUNG CANCER
- Being tested
- 23-valent pneumococcal vaccine
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
23-valent pneumococcal vaccineBiological
Receive the 23-valent pneumococcal vaccine; Do not receive the 23-valent pneumococcal vaccine
| Study group | Role | What they receive |
|---|---|---|
| Vaccination group | Lung cancer patients receive 23-valent pneumonia vaccine Receives: Biological: 23-valent pneumococcal vaccine | |
| Unvaccinated group | Lung cancer patients have not received the 23-valent pneumococcal vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of pneumonia at 12 months
During the 12-month follow-up period, the incidence of pulmonary infection in lung cancer patients was evaluated through regular clinical examinations, imaging tests, and laboratory tests.
Measured: 12 months
Incidence of pneumonia
The proportion of lung cancer patients who developed pneumonia during the study period.
Measured: 24 months
Secondary outcomes (1)
Survival rate
The survival rate of lung cancer patients within a specific time period (such as 1 year, 2 years, or 5 years).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LUNG CANCERStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yalei Zhang, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142057
- Sponsor's protocol ID
- 23V-PNEUMO-LC
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Impact of the 23-valent Pneumonia Vaccine on the Incidence of Pulmonary Infection and Survival in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT07142057
- Acronym / sponsor ID
- 23V-PNEUMO-LC
- Conditions
- LUNG CANCER
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 26 Aug 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.
To evaluate the impact of the 23-valent pneumonia vaccine on the incidence of pulmonary infection and survival in lung cancer patients, and to explore its preventive effect and safety in the lung cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccination group | – | Biological: 23-valent pneumococcal vaccineLung cancer patients receive 23-valent pneumonia vaccine |
| Unvaccinated group | – | –Lung cancer patients have not received the 23-valent pneumococcal vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients can receive or not receive the 23-valent pneumococcal vaccine
Key inclusion criteria (3 listed)
- Male or female patients >=18 years of age;
- Histological diagnosis of NSCLC, including both non-small cell lung cancer and small cell lung cancer, regardless of whether they are in the early, locally advanced stage or advanced stage, and regardless of whether they have received surgery, radiotherapy, chemotherapy or other treatments;
- Never received pneumococcal vaccine
Key exclusion criteria (1 listed)
- Patients having other factors that preventing researchers from enrollment them.
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 |
|---|---|---|
| 23-valent pneumococcal vaccineReceive the 23-valent pneumococcal vaccine; Do not receive the 23-valent pneumococcal vaccine | Biological | Vaccination group |
Primary outcome
The incidence of pneumonia at 12 months
Time frame: 12 months
During the 12-month follow-up period, the incidence of pulmonary infection in lung cancer patients was evaluated through regular clinical examinations, imaging tests, and laboratory tests.
Incidence of pneumonia
Time frame: 24 months
The proportion of lung cancer patients who developed pneumonia during the study period.
1 secondary outcome
Survival rate
Time frame: 5 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 26 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of LUNG CANCER, run by The First Affiliated Hospital of Guangzhou Medical 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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 26 Aug 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of pneumonia at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. 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 26 Aug 2025.