Trials Sponsors Conditions Drugs Pricing

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

Safety of neo-adjuvant durvalumab: number of NCI CTCAE v 5.0 grade ≥3
Demonstrate safety of two courses durvalumab (MEDI4736) 750 mg at two weeks interval in neo-adjuvant setting. Safety is defined as the number of NCI CTCAE v 5.0 grade ≥3 toxicity related to neo-adjuvant durvalumab (MEDI4736).
14 days
Feasibility of neo-adjuvant durvalumab: successful completion of curative surgery
Demonstrate feasibility of two courses durvalumab (MEDI4736) 750 mg at two weeks interval in neo-adjuvant setting. Feasibility is defined as successful completion of curative surgery within 42 days after start of neo-adjuvant treatment with durvalumab (MEDI4736) (= day 1).
42 days

Secondary Outcomes (13)

Imaging related_response on CE-CT
42 days
Imaging related_pathological response
42 days
Imaging related_correlation with Zr89-labelled durvalumab
42 days
Imaging related_correlation with perfusion-CT
42 days
Biomarker related_future correlation with other biomarkers
42 days
+8 more secondary outcomes

Study Arms (1)

Durvalumab (MEDI4736) neo-adjuvant

EXPERIMENTAL

Patients will receive two courses of durvalumab (MEDI4736)at a fixed dose of 750mg Q2W intravenously, prior to scheduled resection of NSCLC. Patients are amendable to adjuvant chemo and/or radiation treatment, per standard-of-care. Additionally, patients will undergo a Zr-89 labelled durvalumab (MEDI4736) PET/CT and dedicated perfusion-CT prior to treatment with durvalumab (MEDI4736) and ex vivo In-111-oxine or in vivo \[89Zr\]-Df-crefmirlimab labelled CD8+ T-cells after two courses of treatment, prior to surgery.

Radiation: Zr-89 labelled durvalumab PET/CTDrug: Durvalumab (MEDI4736)

Interventions

Zr-89 labelled durvalumab PET/CTRadiation

Patients will undergo a Zr-89 labelled durvalumab (MEDI4736) PET/CT and dedicated perfusion-CT prior to treatment with durvalumab (MEDI4736) and in- and ex-vivo In-111-oxine or in-vivo \[89zr\]-Df-crefmirlimab labelled CD8+ T-cells after two courses of treatment, prior to surgery.

Also known as: In-111-oxine labelled CD8+ T-cell scintigraphy OR [89Zr]-Df-crefmirlimab PET, Dedicated perfusion-CT

Durvalumab (MEDI4736) neo-adjuvant

Durvalumab (MEDI4736)Drug

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female subjects aged \>50 years at time of study entry
Histopathological proven primary non-small cell lung cancer, with fully evaluable histological biopsies available

Sponsors & Collaborators

AstraZeneca
Industrycollaborator
Radboud University Medical Center
Otherlead

Study Sites (1)

Radboud University Medical Center

Nijmegen, 6500 HB, Netherlands

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

Erik Aarntzen, MD, PhD
Radboud University Medical Center
PRINCIPAL INVESTIGATOR
Michel van den Heuvel, MD, PhD
Radboud University Medical Center
PRINCIPAL INVESTIGATOR
Jolanda de Vries, MD, PhD
Radboud University Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 25, 2019

Study Start

September 19, 2019

Actual (reported)

You may not qualify if:

Inability to lie supine for more than 30 minutes
Documented previous severe allergic reaction to iodine-based contrast media, despite adequate pre-medication. In case of documented mild to moderate allergic reaction to iodine-based contrast media, patients will receive premedication according to the local protocol, consisting of 25mg prednisolone intravenously 30 minutes prior to iodine-based contrast media administration and 2mg clemastine intravenously just prior to administration.
Indication for cervical mediastinoscopy according to the local multidisciplinary Thoracic-Oncology meeting
Participation in another clinical study with an investigational product during the past 6 months
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
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
Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
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.
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.
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
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
History of allogenic organ transplantation.
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 \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
Patients with vitiligo or alopecia
Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
+23 more criteria

Imaging Tumor-infiltrating T-cells in Non-small Cell Lung Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (13)

Study Arms (1)

Durvalumab (MEDI4736) neo-adjuvant

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (13)

Study Arms (1)

Durvalumab (MEDI4736) neo-adjuvant

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations