Phase III, Open-label, Multicentre, Randomised Trial to Establish Safety and Efficacy of an EGF Cancer Vaccine in Inoperable, Late Stage (IIIb/IV) NSCLC Patients Eligible to Receive Standard Treatment and Supportive Care.
1. Are aged 20-65 years (inclusive).
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Have adequate bone marrow, liver and renal function, as assessed by the Investigator.
A sample taken at Screening should confirm that:
- White blood cell (WBC) count ≥ 3000 per µL
- Platelet count ≥ 100,000 per µL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x
upper limit of normal (ULN) (or ≤ 5 x ULN when liver metastases are present)
- Total bilirubin ≤ 1.5 x ULN
- Serum creatinine ≤ 1.5 x ULN
4. Have histologically and/or cytologically confirmed diagnosis of NSCLC, corresponding
to locally and regionally advanced, inoperable disease (Stage IIIb or Stage IV [as
defined by the American Joint Committee on Cancer staging system]), excluding brain
5. Are eligible to receive first-line chemotherapy (without concurrent thoracic
radiotherapy or consolidation radiotherapy).
6. Agree to use double-barrier contraception (males and females alike [if applicable]).
A negative pregnancy test must be documented at Screening for females of childbearing
Note: Females of childbearing potential are defined as those women with less than 2
years after last menstruation and not surgically sterile, while post-menopausal
refers to those women with at least 2 years from last menstruation.
7. Have signed a voluntary written informed consent form (ICF). Patients should be
cooperative, willing and able to participate and adhere to the Protocol requirements,
including their availability for the follow-up.
1. Patient has no measurable disease (as defined by RECIST criteria, version 1.1).
2. Patient is a candidate for concurrent chemo-radiotherapy or post chemo thoracic
3. Patient has a history of known or suspected central nervous system (CNS) metastases.
4. Patient has a history of primary malignancy (except resected non-melanoma skin cancer
or curatively treated carcinoma in situ of the cervix), unless in complete remission
and off all chemotherapy and/or radiotherapy for that disease for a minimum of 5
5. Patient is taking immunosuppressant drugs such as azathioprine, tacrolimus,
cyclosporine, etc. Use is not permitted within 1 month before Screening.
6. Patient is taking any other immunotherapy.
7. Patient has primary or secondary immunodeficiencies (e.g. documented Human
Immunodeficiency Virus [HIV]).
8. Patient has autoimmune disease.
9. Patient has undergone splenectomy.
10. Patient is taking oral, intramuscular or intravenous corticosteroids. Use is not
permitted within 1 month before Screening. Inhaled corticosteroids to treat
respiratory insufficiency (e.g. chronic obstructive pulmonary disease [COPD]), or
topical steroids are permitted.
11. Patient has a neurotoxicity (Grade ≥2).
12. Patient has diarrhoea (Grade ≥2).
13. Patient has received other vaccines (with the exception of the influenza vaccine),
within 1 month before Screening.
14. Patient has a history of any severe or life-threatening hypersensitivity reaction.
15. Patient has an unstable systemic disease (including active infection, uncontrolled
hypertension, unstable angina, congestive heart failure, myocardial infarction within
the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal
and metabolic disease).
16. Patient has recent history (within 6 months before Screening) of chronic alcohol or
drug abuse which may compromise the patient's safety or ability to participate in
17. Patient has a history of psychiatric disorder that prevents patients from providing
informed consent or following Protocol instructions.
18. Patient is currently enrolled in an investigational device or drug trial, or <1 month
since completing an investigational device or drug trial.
19. Female patients who are pregnant or lactating.
20. Patient has any other factor that in the opinion of the Investigator (or designee)
would make the patient unsafe or unsuitable for the study.