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.
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.
Life expectance less than 3 months.
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.
Parallel
Any Chinese government-recommended COVID-19 booster vaccine
Biological/VaccineAny Chinese government-recommended COVID-19 booster vaccine(such as Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine(Sf9 Cell) and so on) will be once administered in the sixth month after COVID19 infection.
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.
The incidence of any of the following events: confirmed COVID 19 infection by antigen test or PCR test, with at least one related symptom including fever, cough, expectoration, dyspnea, headache, diarrhea and so on.
Incidence of critical and/or severe symptomatic COVID-19 infection among lung cancer patients treated with systemic antitumor therapies who get vaccinated 6 months after COVID-19 infection.
The incidence of the following events: COVID 19 infection confirmed by antigen test or PCR test and diagnosed of critical and/or severe pneumonitis.
All-cause mortality rate
The proportions of patients who died from any causes after enrollment.
Overall survival
The time length from enrollment to death from any causes.
Incidence of antitumor drug-related adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Evaluate adverse events of any cause(except cancer-related events), treatment-related adverse events, immune-mediated adverse events according to NCI-CTCAE V5.0.
Exploratory biomarker analysis
5 ml blood samples will be collected in the 3rd ,4.5th and 6th months after symptomatic infection and at the same timepoints after booster dose vaccination(the interventional group) or of the successive 6 months(control group) to monitor the titre of specific sero-antibodies against COVID-19.
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