Clinical trial · Observational
Impact of Inactivated Trivalent Influenza Vaccine on NSCLC Patients Receiving PD-1 / PD-L1 Inhibitors
A Cohort Study to Evaluate the Impact of Inactivated Trivalent Influenza Vaccine on the Immunogenicity, Safety and Survival of Non-small Cell Lung Cancer Patients Receiving PD-1 / PD-L1 Inhibitors
NCT04355806CI-TRIAL-00044770unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This project is to assess the immunogenicity, safety and overall survival impact of intramuscular injection of trivalent influenza vaccine in non-small cell lung cancer (NSCLC) patients with PD-1/PD-L1 inhibitor treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Influenza Vaccine | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inactivated trivalent influenza vaccine | Biological | — | UNRESOLVED |
| PD-1/PD-L1 inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Vaccinated NSCLC group
- description
- This group contains 100 NSCLC patients receiving PD-1/PD-L1 inhibitors for more than 6 months, who will be intramuscularly injected one dose of inactivated trivalent influenza vaccine in influenza seasons 2020-21 or 2021-22 (November-May).
- interventionNames
- Drug: PD-1/PD-L1 inhibitors
- Biological: Inactivated trivalent influenza vaccine
- label
- Vaccinated Health group
- description
- This group contains 30 healthy participants without immunosuppressive diseases, who will be intramuscularly injected one dose of inactivated trivalent influenza vaccine in influenza seasons 2020-21 or 2021-22 (November-May).
- interventionNames
- Biological: Inactivated trivalent influenza vaccine
- label
- Unvaccinated NSCLC group
- description
- This group contains 30 NSCLC patients receiving PD-1/PD-L1 inhibitors for more than 6 months without intramuscular injection of any inactivated trivalent influenza vaccine in influenza seasons 2020-21 or 2021-22 (November-May).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. NSCLC patients were diagnosed with clear pathological classification and receive PD-1 / PD-L1 inhibitor treatment during this project. 2. NSCLC patients have the exact start and end time of PD-1 / PD-L1 inhibitor and / or the vaccination time and follow-up information. 3. The healthy participants are not in an immunosuppressive state, such as cancer, HIV, autoimmune diseases, and long-term use of immunosuppressive drugs. 4. The healthy participants have exact vaccination time. 5. All participants have complete clinical and laboratory diagnostic data. 6. All participants are 18-75 years, regardless of gender. 7. All participants have agreed and signed the consent form before enrollment. Exclusion Criteria: 1. Patients with unclear diagnosis of lung cancer were excluded. 2. Patients with incomplete clinical data or incomplete follow-up records. 3. Patients without signed informed consent. 4. Patient has received blood transfusion within three months. 5. Patients with HIV, Hepatitis B and Hepatitis C infections.
References
Publications (0)
Data not yet available
No reference posted for this study.