NCT04392505

Durvalumab(MEDI4736) After chemoRadioTherapy(DART) for NSCLC-a Translational and Biomarker Study

Durvalumab (MEDI4736) After chemoRadioTherapy (DART) for NSCLC Patients - a Phase II Translational and Biomarker Study Investigating PDL1 Positive and Negative Patients

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation. The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.

Detailed description

This is an open, multinational, phase 2 trial to investigate the Properties of cancer cells before, during and after treatment with the investigational study drug durvalumab in patients with locally advanced non-small celled lung cancer (NSCLC). Both patients with high and low PD-L1 expression are allowed to participate. Durvalumab (PD-L1 inhibitor) will be administered after a period with standardtreatment with chemotherapy and radiationtherapy (chemoradiotherapy) for around 7 weeks. After maximum 5 weeks break after chemoradiotherapy, durvalumab will be given in the same dose to all patients for up to 12 months. The follow-up include a safety follow-up for up to five years, followed by a survival follow-up for up to a total of ten years. The main aim is to identify and describe biomarkers in different sample types related to chemoradiation followed by durvalumab treatment for stage III PD-L1 negative and positive non-small cell lung cancer (NSCLC) patients' eligible for curatively intended chemoradiation. The hypothesis is that clinical differences in course of disease reflect underlying biological characteristics.

Conditions

• Cancer
• Non Small Cell Lung Cancer
• Non Small Cell Lung Cancer Stage III
• NSCLC
• NSCLC, Stage III

Interventions

Type	Name	Description
DRUG	Durvalumab Injection	Included patients will receive durvalumab (fixed dose, 1500mg Q4W) until progressive disease and no clinical benefit, intolerable toxicity or patient's wish, for a maximum duration of 12 months. Treatment with durvalumab should start \<5 weeks after last radiotherapy dosing.

Timeline

• Start date: 2020-05-11
• Primary completion: 2025-05-01
• Completion: 2033-05-01
• First posted: 2020-05-19
• Last updated: 2024-02-29

Locations

10 sites across 4 countries: Estonia, Finland, Lithuania, Norway