PHASE I/IIa STUDY OF VACCINE THERAPY IN PATIENTS WITH NON-SMALL CELL LUNG CANCER

Phase 1

• Conditions: Patient with metastatic Non Small Cell Lung Cancer (NSCLC) stage IV.; MedDRA version: 15.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001852-20-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-13
• Last Update Posted: 14 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Patient with Non Small Cell Lung Cancer (NSCLC) who has been treated with palliative radiotherapy and/or at least three courses of chemotherapy, and has achieved stable disease (SD), partial response (PR) or complete response (CR) confirmed by CT scan at least 4 weeks after end of treatment. Previous curative radiotherapy is allowed as long as the patient has relapsed and received palliative chemotherapy.

• No evidence of disease progression at the time of inclusion
• Must be ambulatory with an ECOG performance status of 0, 1 or 2
• Must be at least 18 years of age.
• No sign of brain metastases (excluded by MRI of brain ).
•Must have lab values as follows:
- White Blood Cells >= 1.5 x 109/L
- Platelets >= 100 x 109/L
- Hemoglobin >= 9g/dL (>=5.6 mmol/L)
- Creatinine <= 140 µmol/L
- Bilirubin < 20% above the upper limit of normal
- ASAT and ALAT <=1.5 the upper limit of normal
- Albumin >= 2.5 g/L
•Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

• History of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, cervical cancer stage IB or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
• Treatment with any other investigational medicinal product (IMP) within 4 weeks prior to first administration of study drug.
• Adverse reactions to vaccines such as anaphylaxis or other serious reactions.
• History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, sclerodermia, polymyositis-dermatomyositis, juvenile onset insulin-dependent diabetes, or a vasculitic syndrome.
• Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
• Active infection requiring antibiotic therapy.
• Pregnancy or lactation.
• Woman of childbearing potential not using any reliable and adequate contraceptive methods defined as use of oral, implanted, injectable, and mechanical or barrier products for the prevention of pregnancy.
• Known sensitivity to any of the components of the vaccine
• Known hypersensitivity to Leukine®, yeast derived products or any component of the product
• Patients who test positive for hepatitis B, C or HIV.
• Any other anti-tumor treatment within 4 weeks of study entry (including chemotherapy, immunotherapy, endocrine therapy, cytokines, interferons, protease inhibitors and gene therapy).
• Use of not permitted concomitant medication:
- chronic corticosteroids except for asthma inhalers / topical use
- any alternative and complementary drugs.
• Any reason why, in the opinion of the investigator, the patient should not participate.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified