Durvalumab (MEDI4736) After chemoRadioTherapy (DART) for NSCLC patients – a phase II translational and biomarker study investigating PDL1 positive and negative patients - DART (19-14434)

Oslo University Hospital0 sites100 target enrollmentDecember 27, 2019

Overview

No summary available.

Registry

who.int

Start Date

December 27, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Oslo University Hospital

•For inclusion in the study patients must fulfill all of the following criteria:
•1\.Locally\-advanced, unresectable, stage 3 NSCLC (including PET\-CT and MRI\-brain in the diagnostic work\-up).
•2\.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (European Union \[EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol\-related procedures, including screening evaluations.
•3\.Diagnostic biopsy with PDL1 \<1% in 50 patients PDL1 \=1% in 50 patients
•4\.Adequate core or excisional biopsy
•5\.Age \= 18 years at time of study entry
•6\.Eastern Cooperative Oncology Group (ECOG performance status of 0, 1 or 2
•7\.Life expectancy of at least 12 weeks
•8\.Body weight \>30 kg
•9\.Adequate normal organ and marrow function as defined below:

•1\.Non\-small cell lung cancer disease suitable for curative surgery
•2\.Significant cardiac, pulmonary or other medical illness that would limit activity or survival
•3\.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 during the last 2 weeks.
•4\.Any concurrent chemotherapy, Investigational product (IP), biologic\- or homonal therapy for cancer treatment. Concurrent use of hormonal therapy for non\-cancer related conditions (e.g. hormone replacement therapy) is acceptable.
•5\. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
•6\. History of allogenic organ transplantation.
•7\.Active or prior documented autoimmune or inflammatory disorders The following are exceptions to this criterion:
•a.Patients with vitiligo or alopecia
•b.Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
•c.Any chronic skin condition that does not require systemic therapy