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

Sponsor
Oslo University Hospital
Study ID
NCT04392505
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab Injection — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 11, 2020
Status verified
Feb 2024
Primary completion
May 1, 2025
Completion
May 1, 2033

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: The whole study population
    All patients will receive durvalumab for up to 1 months after standard treatment With chemoradiotherapy.

Primary Outcome Measure

Impact of tumour mutational burden (TMB) measured in the tumour tissue and blood samples, on the hazard. [ Time Frame: Throughout study, up to 5 years ]

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