Evaluating COVID-19 vaccine effectiveness in lung cancer patients
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
This study is testing whether getting a COVID-19 booster shot helps lung cancer patients on treatment avoid severe infections and stay healthier compared to those who don’t get the booster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1224 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06168032 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the incidence of recurrent COVID-19 infections, severe pneumonitis, and mortality rates among lung cancer patients receiving systemic antitumor therapies who are vaccinated with a booster dose against those who are not. It is a prospective, open-label, and parallel non-randomized control trial that will also investigate the dynamics of specific antibodies against COVID-19. Blood samples will be collected at various time points to analyze the correlation between antibody levels and breakthrough infections. The study will monitor patient outcomes over a six-month period following vaccination or refusal.
Who should consider this trial
Good fit: Ideal candidates include lung cancer patients aged 18 and older who are undergoing systemic anti-tumor treatments and have a recorded history of COVID-19 infection.
Not a fit: Patients with a life expectancy of less than three months or those who have had a recent COVID-19 infection within the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of COVID-19 vaccination in reducing recurrent infections and improving survival rates among lung cancer patients.
How similar studies have performed: While there have been studies on COVID-19 vaccine effectiveness in general populations, this specific focus on lung cancer patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Mengzhao Wang, MD — Peking Union Medical College Hospital
- Study coordinator: Mengzhao Wang, MD
- Email: mengzhaowang@sina.com
- Phone: +8613911235467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.