A pilot study to evaluate the safety and efficacy of a personalised cancer vaccine in patients with completely resected early stage lung cancer

Phase 1

Recruiting

• Conditions: ung Cancer; Lung Cancer; Cancer - Lung - Non small cell

• Registration Number: ACTRN12619000769189
• Lead Sponsor: niversity of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-23
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 6

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.

Pre-Registration
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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of the peptide vaccine strategy as assessed using CTCAE version 5. [From the time of the first dose of vaccination throughout the study follow-up period (52 weeks)]

Secondary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity of the personalised tumour neo-antigen peptide vaccination by IFN-gamma ELISPOT analysis. [At baseline and weeks 5, 7, 11, 15, 19, 23, 35 and 52]