A Phase I Study of Pembrolizumab anti PD-1 monoclonal antibody in combination with Radiotherapy in locally advanced Non-Small Cell Lung Cancer (NSCLC)

The Christie NHS Foundation Trust0 sites25 target enrollmentJuly 19, 2017

Overview

No summary available.

Registry

who.int

Start Date

July 19, 2017

End Date

December 31, 2020

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Histologically or cytologically confirmed NSCLC
•2\. Unresectable stage III NSCLC not suitable for concurrent chemoradiotherapy i.e;
•2\.1\. Patient unsuitable for cisplatin (eg poor renal function);
•2\.2\. Large volume of disease with predicted dose to thoracic organs at risk that are likely to exceed the constraints for concurrent chemoradiotherapy, in the opinion of a clinical oncologist specialised in lung cancer
•3\. Stage IV NSCLC with dominant chest symptoms and low burden of metastatic disease who may benefit from thoracic RT
•4\. Patient considered suitable for radical radiotherapy
•5\. If chemotherapy has been given previously, the maximum interval between the last day of chemotherapy and the start of radiotherapy must be 6 weeks. The minimum interval between the last day of chemotherapy and the start of Pembrolizumab must be one week
•6\. Age \= 18
•7\. Life expectancy estimated to be greater than 6 months
•8\. Performance status (ECOG) 0 or 1 (see Appendix 1\)

•1\. Mixed non\-small cell and small cell tumours
•2\. Participation in a study of an investigational agent or using an investigational device within 4 weeks prior to the anticipated start of treatment.
•3\. Current or previous malignant disease within 3 years except CIN, non\-melanoma skin cancer and low grade, low stage prostate cancer found as incidental finding and not requiring treatment
•4\. History of interstitial pneumonitis
•5\. Presence of brain metastases confirmed by CT or MR brain (unless suitable for local treatment such as SRS or Neurosurgery)
•6\. History of autoimmune disease requiring steroids or immunosuppressive medication
•7\. Uncontrolled hypothyroidism or hyperthyroidism
•8\. Other diseases requiring immunosuppressive therapy greater than 28 days prior to the anticipated first dose of trial treatment.
•9\. Other diseases requiring systemic glucocorticoid (doses \< \= 10 mg prednisolone or equivalent) prior to the first dose of trial treatment.
•10\. Received a prior autologous or allogeneic organ or tissue transplantation.