NCT06168032 COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research

Trial Parameters

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Brief 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.

Eligibility 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.

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