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

NCT06168032 | Recruiting

• 1 other identifier: K4846
• Study Type: interventional
• Target: 1,224
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Recurrent; Lung Cancer; Vaccination; Antibody; Chemotherapy; Immune Checkpoint Inhibitor

Outcome Measures

Primary Outcomes (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.

  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.

  up to 8 weeks

Secondary Outcomes (5)

• 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.

  up to 8 weeks

• All-cause mortality rate

  up to 8 weeks

• Overall survival

  up to 8 weeks

• Incidence of antitumor drug-related adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  up to 8 weeks

• Incidence of adverse events following immunization

  up to 8 weeks

Other Outcomes (1)

• Exploratory biomarker analysis

  up to 8 weeks

Study Arms (2)

Vaccinated group

EXPERIMENTAL

Any booster doses(without limitations in the subtypes or brands of the vaccines) recommended or approved by Chinese government will be administered once in the 6th months after latest confirmed COVID-19 infection and during the following 6 months, any conditions including repeated COVID19 infection, critical and/or severe conditions and all-cause death will be recorded.

Biological: Any Chinese government-recommended COVID-19 booster vaccine

Non-vaccinated group

NO INTERVENTION

Patients unwilling to get vaccination will be allocated into these group, but any events including recurrent COVID19 infection, critical and/or severe conditions and all-cause death will be recorded in the following six months.

Interventions

Any Chinese government-recommended COVID-19 booster vaccine BIOLOGICAL

Any 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.

Vaccinated group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with histories of severe treatment-related adverse events graded 3rd or higher, including those caused by antitumor therapies or immunization except recoverable granulocytopenia.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mengzhao Wang, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengzhao Wang, MD

CONTACT

+8613911235467; mengzhaowang@sina.com

Yan Xu, MD

CONTACT

+8618500296828; maraxu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 13, 2023
• Study Start: December 8, 2023
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 8, 2026
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)