NCT03644823

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This phase II study will investigate NSCLC patients (stage III-IV, palliative treated) where treatment with a PD1-inhibitor is indicated according to national guidelines. Patients will be treated with a check-point inhibitor combined with radiotherapy (6 Gy x 3) towards lesions (1-2). Atezolizumab is available and reimbursed in the public health system. The radiotherapy dosing is significantly lower than standard stereotactic radiotherapy, and is in accordance with other studies reported in ClinicalTrials.gov. Such a fractionation will putatively induce immunogenic cell death, while being a safe treatment, not likely to induce significant side effects. Whereas the primary endpoint in our clinical study will be toxicity, the secondary endpoints include response rates, overall survival, safety and tolerability, quality of life, progression-free survival and duration of response. In addition, exploratory endpoints will include immunological response, tumor evolution and dynamics in the tumor microenvironment during treatment, imaging, and biomarkers of clinical response.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	PDL1- inhibitor
RADIATION	Radiotherapy	6 Gy x 3

Timeline

• Start date: 2018-08-15
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-08-23
• Last updated: 2021-03-30

Locations

1 site across 1 country: Norway