BP40657 - Atezolizumab SC in patients with NSCLC

• Research type

  Research Study

• Full title

  A TWO-PART PHASE Ib/II STUDY TO INVESTIGATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF ATEZOLIZUMAB SUBCUTANEOUS IN PATIENTS WITH STAGE IV NONSMALL CELL LUNG CANCER

• IRAS ID

  253270

• Contact name

  Shobhit Baijal

• Contact email

  shobhit.baijal@heartofengland.nhs.uk

• Sponsor organisation

  F. Hoffman-La Roche Ltd.

• Eudract number

  2018-002328-18

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  4 years, 5 months, days

• Research summary

  Research Summary

  Lung cancer remains the leading cause of cancer deaths worldwide.NonSmall Cell Lung Cancer (NSCLC) is the predominant subtype of lung cancer accounting for approximately 85% of all cases.\nDespite recent advances in the treatment options for patients with metastatic NSCLC,the majority of patients will ultimately relapse and die from their disease.Continued research into new drugs and combination therapies is required to expand the clinical benefit to a broader patient population and to improve outcomes in NSCLC.Immune checkpoint inhibitors,including PD-L1/PD-1 blocking antibodies,have recently emerged as a standard therapeutic option for first-line treatment of metastatic NSCLC.\nAtezolizumab is a humanized IgG1 monoclonal antibody that targets PD-L1 and inhibits the interaction between PD-L1 and its receptors,PD-1 and B7-1,both of which function as inhibitory receptors expressed on T cells.Therapeutic blockade of PD-L1 binding by atezolizumab has been shown to enhance the magnitude and quality of tumor-specific T-cell responses, resulting in improved anti-tumor activity.Atezolizumab IV is approved for the treatment of locally advanced or metastatic urothelial cell carcinoma and NSCLC.Atezolizumab IV is infused over a period of 60 minutes.Subsequent infusions are delivered in 30 minutes if the previous infusion was tolerated without reaction.For many patients,the long infusion time,as well as the need for repeated invasive IV access,is a disadvantage of the current therapeutic approach.In view of the above aspects,a new product of atezolizumab for SC injection is being developed (atezolizumab SC).This study will evaluate the pharmacokinetics,safety,and efficacy of atezolizumab SC compared with atezolizumab IV in patients with NSCLC.\n236 patients will be recruited globally.36 to part 1 (dose finding) over 3 cohorts and 200 to part 2 (dose confirmation).\nThe study will last 4 years 7 months globally. There will be approximately 4 patients in the UK over 2 sites.\nThe study is sponsored by F. Hoffman La Roche\nResearch Summary; Version 1 15/8/18

  Summary of Results

  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fforpatients.roche.com%252Fen%252Ftrials%252Fcancer%252Flung-cancer%252Fa-study-to-investigate-the-pharmacokinetics--efficacy---50110.html%2FNBTI%2FHPrAAQ%2FAQ%2F7ff30fde-d162-4c6b-a55a-61bdb2289eff%2F1%2FldjJMusLGX&data=05%7C02%7Cleedseast.rec%40hra.nhs.uk%7C2cb89318271c4cc1e90a08de154487bf%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638971581244187900%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=SZTXSG4Rra0eao8Q4oHJLdhgkwGVOvOs2gdxeVRTBbA%3D&reserved=0

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  18/YH/0393

• Date of REC Opinion

  9 Nov 2018

• REC opinion

  Further Information Favourable Opinion