Clinical trial NCT06168032: COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19 Recurrent
Lung Cancer
Vaccination
Antibody
Chemotherapy
Immune Checkpoint Inhibitor
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 1224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: A single booster dose will be administered depending on patients' willingness in the sixth month after symptomatic COVID-19 infection and status including repeated COVID19 infection, critical and/or severe conditions and all-cause death will be recorded during the next 6 months after vaccination or not. For antibody analysis, 5 ml blood samples will be collected from all of the included patients respectively in the 3rd ,4.5th and 6th months after latest occurrence of symptomatic infection and at the same timepoints after booster dose 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.

Primary outcomes:
measure: 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.
timeFrame: up to 8 weeks
Secondary outcomes:
measure: 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.
timeFrame: up to 8 weeks
measure: All-cause mortality rate
timeFrame: up to 8 weeks
measure: Overall survival
timeFrame: up to 8 weeks
measure: Incidence of antitumor drug-related adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
timeFrame: up to 8 weeks
measure: Incidence of adverse events following immunization
timeFrame: up to 8 weeks
Other outcomes:
measure: Exploratory biomarker analysis
timeFrame: up to 8 weeks
Locations:
city: Peking
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Mengzhao Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: