Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Evaluating COVID-19 vaccine effectiveness in lung cancer patients

Official title: Efficacy of COVID-19 Booster-Dose Vaccine for Re-infection Precaution and Dynamics of Specific Serum Antibodies in the Management of Lung Cancer Patients With Systemic Anti-cancer Treatment

Run by Peking Union Medical College Hospital · NCT06168032 · Data updated 2026-11-12

This study is testing whether getting a COVID-19 booster shot helps lung cancer patients on treatment avoid severe infections and stay healthier compared to those who don’t get the booster.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1224 (estimated)
SponsorPeking Union Medical College Hospital
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Beijing)
StatusRecruiting
StartedDecember 8, 2023
Main results expectedDecember 8, 2026
Study endsDecember 8, 2026
Registry record updatedDecember 13, 2023
Trial IDNCT06168032 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include lung cancer patients aged 18 and older who are undergoing systemic anti-tumor treatments and have a recorded history of COVID-19 infection.

Probably not a fit

Patients with a life expectancy of less than three months or those who have had a recent COVID-19 infection within the last three months may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the incidence of recurrent COVID-19 infections, severe pneumonitis, and mortality rates among lung cancer patients receiving systemic antitumor therapies who are vaccinated with a booster dose against those who are not. It is a prospective, open-label, and parallel non-randomized control trial that will also investigate the dynamics of specific antibodies against COVID-19. Blood samples will be collected at various time points to analyze the correlation between antibody levels and breakthrough infections. The study will monitor patient outcomes over a six-month period following vaccination or refusal.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of COVID-19 vaccination in reducing recurrent infections and improving survival rates among lung cancer patients.

How similar studies have gone: While there have been studies on COVID-19 vaccine effectiveness in general populations, this specific focus on lung cancer patients is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patients who agree to participate in the trial and sign the informed consents.
2. Male or female, ≥18 years old.
3. Diagnosed of lung carcinoma by histological and cytological examinations.
4. Undergoing systemic anti-tumor treatments including chemotherapy, immunotherapy, chemoimmunotherapy and targeted therapy.
5. Recorded history of COVID19 infection.
6. Sufficiently functional organs.
7. Eastern Cooperative Oncology Group performance score (PS) ranging from 0 to 2.

Exclusion Criteria:

1. Life expectance less than 3 months.
2. Less than 3 months since last confirmed COVID-19 infection.
3. Patients unable to return the hospital for follow-up.
4. Patients allergic to COVID-19 vaccine.
5. Patients with histories of severe treatment-related adverse events graded 3rd or higher, including those caused by antitumor therapies or immunization except recoverable granulocytopenia.

Where it's running

  • Peking Union Medical College Hospital
    Beijing, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.