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Clinical Trials/EUCTR2019-002537-11-LT
EUCTR2019-002537-11-LT
Active, not recruiting
Phase 1

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 enrollmentFebruary 13, 2020
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Conditionson-small cell lung cancer (NLCLC)MedDRA version: 21.1Level: 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]
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
on-small cell lung cancer (NLCLC)
Sponsor
Oslo University Hospital
Enrollment
100
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 13, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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), biologicor 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

Outcomes

Primary Outcomes

Not specified

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