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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to evaluate the safety and efficacy of a personalised cancer vaccine in patients with completely resected early stage lung cancer
Scientific title
A pilot study to evaluate the safety and immunogenicity of a personalised tumour neo-antigen peptide vaccine strategy in patients with completely resected non-small cell lung cancer.
Secondary ID [1] 298271 0
Universal Trial Number (UTN)
Trial acronym
ATTAC (Antigen-targeted therapy against cancer)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 312883 0
Condition category
Condition code
Cancer 311377 311377 0 0
Lung - Non small cell

Study type
Description of intervention(s) / exposure
Neoantigen peptide vaccine containing 5 - 10 peptides per vaccine depending on how many high affinity binding neo-antigens are predicted for each patient (ie some patients may only have 5 high affinity neo-antigens identified)
The vaccine will be administered 2 weekly for 4 doses then 4 weekly for 4 doses as a subcutaneous injection (fortnightly for the first 4 doses then 4 weekly for the next 4 doses)

Patients are provided with treatment schedule and will be reviewed by clinician prior to each dose for safety monitoring. CRFs will be completed for each visit.

Each dose will include 500mcg - 1000mcg of synthetic peptide (100mcg per peptide) in 0.5mL of Montanide as adjuvant by subcutaneous administration
Intervention code [1] 314515 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group

Primary outcome [1] 320107 0
To evaluate the safety of the peptide vaccine strategy as assessed using CTCAE version 5.
Timepoint [1] 320107 0
From the time of the first dose of vaccination throughout the study follow-up period (52 weeks)
Secondary outcome [1] 370553 0
To evaluate the immunogenicity of the personalised tumour neo-antigen peptide vaccination by IFN-gamma ELISPOT analysis.
Timepoint [1] 370553 0
At baseline and weeks 5, 7, 11, 15, 19, 23, 35 and 52

Key inclusion criteria
1. Pathologically established diagnosis of NSCLC
2. Localised disease amenable to complete surgical resection
3. > 18 years of age
4. Eastern Cooperative Oncology Group (ECOG) performance status =1.
5. Life expectancy of >24 weeks
6. Patients who may require adjuvant chemotherapy are eligible
7. History of prior malignancy is eligible if the following criteria are met for a cancersurvivor:
7.1. has undergone potentially curative therapy for all prior malignancies,
7.2. has been considered disease free for at least 2 years
8. Women of reproductive potential must agree to use adequate contraception (two barrier methods or barrier method plus hormonal method of birth control; abstinence) prior to study entry and for the duration of study participation.
9. Males who are sexually active with women of reproductive potential must agree to use adequate contraception (two barrier methods or abstinence) prior to study entry and for the duration of study participation.
10. Able to provide written informed consent.
11. Must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.

12. Complete resection with margins negative for disease.
13. If required. Completed adjuvant platinum doublet chemotherapy as per standard oncological management
14. Adequate organ and marrow function no more than 14 days prior to registration as defined below:
Haemoglobin = 90g/L
WBC > 2 x 109/L
absolute neutrophil count > 1.5 x 109/L
platelets > 100 x 109/L
total bilirubin < 1.5 x ULN
ALT < 3.0 x ULN
creatinine < 1.5 x ULN
15. Adequate number of accessible tumour cells from resection.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Received chemotherapy, radiotherapy, or biologic therapy or other investigational therapeutic agent(s) within the last 21 days
2. Ongoing adverse effects from chemotherapy that have not resolved to = grade 1 (except haemoglobin= 90g/L is allowed)
3. Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, urticaria, or respiratory difficulty.
4. Uncontrolled significant intercurrent illness of major organ systems, or has psychiatric illness/social situation that would limit compliance with study requirements.
5. Prior or currently active significant autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism requiring only hormone replacement are permitted to enroll.
6. Subjects with a condition requiring systemic corticosteroids or other immunosuppressive medications within 14 days of study treatment. Inhaled steroids and adrenal replacement steroids are permitted in the absence of active autoimmune disease.
7. Pregnant or breastfeeding. A negative serum pregnancy test is required in women of childbearing
potential no more than 7 days before registration.
8. Known HIV-positive status.
9. Any positive test result for Hepatitis B virus or hepatitis C virus indicating the presence of virus, e.g. Hepatitis B surface antigen (HBsAg) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).
10. Known medical condition that, in the investigator’s opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
11. Subjects in whom the ability to observe possible local reactions at the eligible injection sites is, in the
opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.
12. Therapeutic or traumatic metal implant in the skin or muscle of eligible injection sites.
13. Prisoners or subjects who are involuntarily incarcerated.
14. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 302814 0
Government body
Name [1] 302814 0
Country [1] 302814 0
Primary sponsor type
University of Western Australia
35 Stirling Hwy, Crawley WA 6009
Secondary sponsor category [1] 302765 0
Name [1] 302765 0
Address [1] 302765 0
Country [1] 302765 0

Ethics approval
Ethics application status
Ethics committee name [1] 303397 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 303397 0

2nd Floor A Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Ethics committee country [1] 303397 0
Date submitted for ethics approval [1] 303397 0
Approval date [1] 303397 0
Ethics approval number [1] 303397 0

Brief summary
This is a pilot study to evaluate the safety of a personalized tumour neo-antigen peptide vaccine strategy in non-small cell lung cancer (NSCLC).

Who is it for?

You may be eligible for this study if you are an adult who has been diagnosed with early stage non-small cell lung cancer and is planned for surgery.

Study details

All participants in this study will be required to attend the Sir Charles Gardner Hospital to receive a vaccine fortnightly for the first 4 doses (8 weeks), and then 4 weekly for another 4 doses (16 weeks). You will monitored with blood tests before each dose.

This research project hopes to discover a new and effective treatment for patients with non-small cell lung cancer.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 93534 0
Prof Bruce Robinson
Address 93534 0
UWA School of Medicine and Pharmacology,
Level 5, Harry Perkins Research Building,
QEII Medical Centre, Nedlands, Perth, WA, 6009
Country 93534 0
Phone 93534 0
+61 8 6151 0923
Fax 93534 0
Email 93534 0
Contact person for public queries
Name 93535 0
Dr Linda Ye
Address 93535 0
Department of Medical Oncology
Sir Charles Gairdner Hospital
Hospital Ave Nedlands, WA, 6009
Country 93535 0
Phone 93535 0
+61 8 6457 3333
Fax 93535 0
Email 93535 0
Contact person for scientific queries
Name 93536 0
Dr Linda Ye
Address 93536 0
Department of Medical Oncology
Sir Charles Gairdner Hospital
Hospital Ave Nedlands, WA, 6009
Country 93536 0
Phone 93536 0
+61 8 6457 3333
Fax 93536 0
Email 93536 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided
Current supporting documents:

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Current Lung Cancer Neoantigen Landscape and Implications for Therapy.2021
Dimensions AIDevelopment of tumour peptide vaccines: From universalization to personalization2020