EUCTR2019-000670-37-NLActive, not recruitingPhase 1
Imaging tumor-infiltrating CD8+ T-cells in non-small cell lung cancer upon neo-adjuvant treatment with Durvalumab (MEDI4736). - DONAN trial
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •All patients must meet all of the following criteria:
- •1. Male or female subjects aged >50 years at time of study entry
- •2. Histopathological proven primary non-small cell lung cancer, with fully evaluable histological biopsies available
- •3. ECOG performance status of 0 or 1
- •4. AJCC stage I, II or IIIa as determined by contrast-enhanced CT chest-abdomen and F-18-FDG PET/CT: cT1cN0-1M0, cT2aN0-1M0 en cT3N0-1M0 (T3 separate nodule)
- •5. Solid appearance of the tumor on contrast-enhanced CT
- •6. Scheduled for resection with curative intent
- •7. Patients should be medically operable defined by:
- •8. Sufficient cardiopulmonary function
- •9. Major contra-indications for surgery.
- •10. No underlying immune disease (neutro- or lymphopenia, coagulation disorders) that could interfere with T-cell isolation
- •11. Life expectancy at least 6 months
- •12. Written informed consent and comply with study protocol for the duration of the study and follow-up
- •13. Adequate laboratory values (refer to study protocol)
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •A patient will be excluded from participation in the trial if one or more of the following criteria are met:
- •1. Inability to lie supine for more than 30 minutes
- •2. Documented previous severe allergic reaction to iodine-based contrast media, despite adequate pre-medication.
- •3. Indication for cervical mediastinoscopy
- •4. Participation in another clinical study with an investigational product during the past 6 months
- •5. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- •6. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal antibodies) <6 months prior to the first dose of study drug
- •7. Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- •8. Patients with Grade =2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
- •9. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab (MEDI4736) may be included only after consultation with the Study Physician.
- •10. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- •11. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 6 months of the first dose of study drug
- •12. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
- •13. History of allogenic organ transplantation.
- •14. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).
- •15. History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease =5 years before the first dose of IP and of low potential risk for recurrence, Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, Adequately treated carcinoma in situ without evidence of disease
- •16. History of active primary immunodeficiency
- •17. Active infection including: tuberculosis, hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, human immunodeficiency virus (positive HIV 1/2 antibodies), Epstein Barr Virus (EBV, positive IgM antibodies), cytomegalo virus (CMV, positive IgM antibodies)
- •18. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab (MEDI4736); exceptions apply.
- •19. Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab (MEDI4736). Note: Patients, if enrol
Investigators
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