Imaging tumor-infiltrating T-cells in non-small cell lung cancer.

Phase 1

• Conditions: Patients with non-small cell lung carcinoma (NSCLC).; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000670-37-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-14
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

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

Study & Design

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