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NCT Number: NCT07142057

An Observational Study on the Impact of the 23-valent Pneumonia Vaccine on 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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

Patients having other factors that preventing researchers from enrollment them.

Treatment and study plan

23-valent pneumococcal vaccine

Biological

Receive the 23-valent pneumococcal vaccine; Do not receive the 23-valent pneumococcal vaccine

Primary outcomes

  1. 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.

  2. Incidence of pneumonia

    Time frame: 24 months

    The proportion of lung cancer patients who developed pneumonia during the study period.

Secondary outcomes

  1. Survival rate

    Time frame: 5 years

    The survival rate of lung cancer patients within a specific time period (such as 1 year, 2 years, or 5 years).

Other outcomes

  1. Lung cancer-related complications

    Time frame: 5 years

    The incidence of complications related to lung cancer (such as respiratory failure, infection, etc.).

  2. Length of hospital stay

    Time frame: 5 years

    Record the number of days of hospitalization for patients hospitalized due to lung infection.

  3. Hospitalization rate

    Time frame: 5 years

    The proportion of patients hospitalized due to pneumonia or other related complications.

  4. Antibiotic usage

    Time frame: 5 years

    This includes the types, dosages, and durations of antibiotic usage, etc

  5. Quality of life of lung cancer patients

    Time frame: 5 years

    Specific quality of life assessment scales are used, such as standardized quality of life assessment tools (such as EORTC QLQ-C30) to evaluate the quality of life of patients.

  6. Immune response

    Time frame: 5 years

    The immune response (such as antibody levels) of patients after vaccination is evaluated through serological testing.

  7. Adverse reactions after vaccination

    Time frame: 30 days

    Observe whether patients who receive the 23-valent pneumococcal vaccine experience adverse reactions after vaccination, such as fever, redness, swelling and pain at the injection site, headache, dizziness, etc.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Aug 26, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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