Surgically resected stage 1A/1B non small cell lung cancer Cancer
Conditions
Interventions
This phase of the LungVax trial includes two cohorts. Both cohorts will receive the intervention, ChAdOx2 LungVax, via intramuscular injection at a dose of 5 x 10^10 vp on day (D)0 and D28, month (M)1
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion criteria
Inclusion criteria: Cohort 1: 1. Age =18 years. 2. Histological confirmation of NSCLC. 3. Curative surgery in keeping with NICE guidelines for stage IA or IB NSCLC = 3 months of D0. 4. Post-operative imaging confirming no active cancer (within 3 months/=90 (+/- 7) days of Day 0). 5. Laboratory parameters (tested during screening period and results obtained prior to vaccine administration) within the ranges specified in the protocol. 6. For participants of childbearing potential only (as defined by protocol section 5.1): willing to use effective contraception for the duration of the study and a negative pregnancy test on the days of screening and vaccination. 7. Willing and able to comply with the protocol scheduled visits and investigations for the duration of the trial. Cohort 2: 1. Age 55–74 years inclusive, in accordance with NHS Lung Cancer Screening Programme eligibility. 2. Participating in NHS Lung Cancer Screening Programme with recent (within 3 months/=90 (+/- 7) days of Day 0) low dose CT scan/or other imaging confirming no active cancer or suspicion of cancer. 3. Haemoglobin (Hb), white cell count (WCC) and platelets (tested during screening period, prior to vaccine administration) within the normal ranges specified (local lab ranges). 4. For participants of childbearing potential only (as defined by protocol section 5.1): willing to use effective contraception for the duration of the study and a negative pregnancy test on the days of screening and vaccination. 5. Willing and able to comply with the protocol scheduled visits and investigations for the duration of the trial.
Exclusion criteria
Exclusion criteria: Cohort 1: 1. Positive surgical margins or incomplete resection (R2 macroscopic resection on post-operative pathological assessment). 2. Other/active malignancy or cancer requiring systemic treatment within the past 2 years apart from non-melanomatous skin cancer, stage 0 melanoma in situ, breast ductal carcinoma in situ (DCIS), polyps and in situ cervical cancer. Or, other new or recurrent cancer diagnosed previously that is currently being treated or maintained in remission (including by hormonal therapy). 3. Prior, or eligible for, neoadjuvant or adjuvant treatment. 4. Currently pregnant or breast-feeding. 5. Prior history of thromboembolic events such as myocardial infarction, angina, cerebrovascular accident/TIA/stroke, pulmonary embolus or deep vein thrombosis. 6. History of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2). 7. Active autoimmune disease. e.g. Crohn’s disease, rheumatoid arthritis. 8. Confirmed active diagnosis of known high-risk infections (e.g., Human Immunodeficiency Virus) (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection, tuberculosis and Creutzfeldt-Jacob disease) unless participant case is of a particular scientific interest and agreed in advance with CI or delegate. 9. Any significant or uncontrolled disease or condition that, in the clinical judgment of the treating physician, is likely to interfere with evaluation of trial treatment, interpretation of participant safety or trial results, prevent the participant from complying with any aspect of the protocol or that may put the participant at unacceptable risk. 10. Live or live-attenuated vaccine administered less than 14 days before the first ChAdOx2 LungVax vaccination (Day 0). 11. Any disorder that is clinically relevant to the participants current health or vaccine response, as judged by the investigator, including known primary or secondary immunodeficiencies, ongoing immunosuppressive therapy, or laboratory evidence of immune compromise. 12. Severe hypersensitivity (=Grade 3) to ChAdOx1-containing vaccines and/or any of their excipients. 13. Prior administration of ChAdOx2 vaccine. 14. Severe allergy to eggs or any previous vaccination. 15. Current participation in another interventional clinical trial involving the administration of an investigational medicinal product. Cohort 2: 1. Active malignancy or cancer requiring systemic treatment within the past 2 years apart from non-melanomatous skin cancer, stage 0 melanoma in situ, breast ductal carcinoma in situ (DCIS), polyps and in situ cervical cancer. Or, other new or recurrent cancer diagnosed previously that is currently being treated or maintained in remission (including by hormonal therapy). 2. Currently pregnant or breast-feeding. 3. Prior history of thromboembolic events such as myocardial infarction, angina, cerebrovascular accident/TIA/stroke, pulmonary embolus or deep vein thrombosis. 4. History of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2). 5. Active autoimmune disease. e.g. Crohn’s disease, rheumatoid arthritis. 6. Confirmed active diagnosis of known high-risk infections (e.g., Human Immunodeficiency Virus) (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection, tuberculosis and Creutzfeldt-Jacob disease) unless participant case is of a particular scientific interest and agreed in advance with CI or delegate. 7. Any significant or uncontrolled disease or condition that, in the c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number and severity of adverse events (AEs) within the DLT evaluable period (28 days after first vaccination at D0) within each cohort. Measured using vaccine-emergent AEs or clinically significant laboratory changes (per CTCAE v6.0) or changes in vital signs within each cohort 2.Magnitude of vaccine antigen specific cellular immunogenicity using peripheral-blood mononuclear cells (PBMCs) (e.g. for Interferon gamma (IFN?) enzyme-linked immunospot (ELISpot) assay). Measured at Day 0 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total number and severity of AESIs and SAEs in each cohort (within and outside the DLT evaluable period), comprising treatment - emergent AESIs and SAEs. Measured at 24 months after vaccination at Day 0 or Early Withdrawal Visit (EWV) 2. Breadth of vaccine antigen specific immune responses defined as the number of peptides/peptide pools targeted by vaccine specific T cells at peak response (spot-forming units (SFUs)/million PBMCs) relative to negative control in each assay. Measured at Day 0 and Day 14 3. Cellular immunogenicity (as above for primary end point). Measured during the 24-month follow-up and at 24 months after vaccination at Day 0 4. Responses to vaccine antigens restricted by Human leukocyte antigens (HLA) alleles, e.g. using ELISpot (and/or intracellular cytokine assays) against selected peptide antigens. Measured during the 24-month follow-up and at 24 months after vaccination at Day 0 | — |
Countries
England, United Kingdom
Contacts
Public Contact- Oncology Clinical Trials Office
Outcome results
None listed