Combinatory ImmunoTherapy-1 (Com-IT-1) Irradiation and PD-1 Blockade in Locally Advanced / Advanced NSCLC

Sponsor
Oslo University Hospital
Study ID
NCT03644823
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    PDL1- inhibitor
  • Radiotherapy — RADIATION
    6 Gy x 3

Study Details

In this study, the investigators will investigate toxicity in patients treated with a Programmed cell death protein 1 (PD-1) inhibitor and radiotherapy. Patients with advanced Non-Small Cell Lung Cancer (NSCLC) can be included when treatment with a PD-1 inhibitor is indicated according to national guidelines. Included patients will receive stereotactic radiotherapy to one or two tumour lesion(s) in addition to the PD-1 inhibitor, and toxicity is the primary endpoint.

Key Dates

Start date
Aug 15, 2018
Status verified
Mar 2021
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PDL1-inhibitor and radiotherapy
    PDL1-inhibitor (Atezolizumab) and Radiotherapy (6 Gy x 3)

Primary Outcome Measure

Incidence, nature, and severity of adverse events graded according to NCI CTCAE v4.0 [ Time Frame: 24 months ]

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