COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomark… (NCT06168032) | Clinical Trial Compass
RecruitingNot Applicable
COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research
China1,224 participantsStarted 2023-12-08
Plain-language summary
A prospective, open-label and parallel non-randomized control trial and biomarker research study is intended to compare incidence of repeated COVID-19 infection, severe pneumonitis and mortality between lung cancer patients undergoing systemic antitumor therapies who get vaccinated with 1 booster dose(majorly against XBB) and those who refuse. Meanwhile, a biomarker research is designed to monitor serum level dynamics of specific antibodies against COVID-19,analyze its correlation with incidence of breakthrough infection and further explore optimal periods for vaccination.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients who agree to participate in the trial and sign the informed consents.
. Male or female, ≥18 years old.
. Diagnosed of lung carcinoma by histological and cytological examinations.
. Undergoing systemic anti-tumor treatments including chemotherapy, immunotherapy, chemoimmunotherapy and targeted therapy.
. Recorded history of COVID19 infection.
. Sufficiently functional organs.
. Eastern Cooperative Oncology Group performance score (PS) ranging from 0 to 2.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of recurrent symptomatic COVID-19 infection among lung cancer patients treated with systemic antitumor therapies who get vaccinated 6 months after COVID-19 infection.
. Less than 3 months since last confirmed COVID-19 infection.
. Patients unable to return the hospital for follow-up.
. Patients allergic to COVID-19 vaccine.
. Patients with histories of severe treatment-related adverse events graded 3rd or higher, including those caused by antitumor therapies or immunization except recoverable granulocytopenia.