PACIFIC-4/RTOG-3515: SBRT with Durvalumab/Placebo in Stage I/II NSCLC

• Research type

  Research Study

• Full title

  A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)

• IRAS ID

  255167

• Contact name

• Contact email

  UKRegulatoryAffairs@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2018-002572-41

• Duration of Study in the UK

  5 years, 11 months, 26 days

• Research summary

  This study will test a new way of treating patients who have a certain type of lung cancer, who would be receiving a type of radiotherapy called stereotactic body radiation therapy (SBRT, or Stereotactic Ablative Radiotherapy (SABR) in the UK) as their primary standard of care treatment. The study will check how effective, safe and tolerable the new treatment is (durvalumab, after completion of SBRT). The new treatment aims to reduce the number of patients whose lung cancer returns after SBRT treatment alone, and to increase cure rates. It’s hoped it will be more effective, but it’s not known at present which is why the study is being performed.

  The study will include approximately 630 subjects, at sites with expertise in the treatment of lung cancer. To participate, patients must be >18 years, have non-small cell lung cancer (NSCLC) in one lung lobe and have SBRT planned. A tissue sample (biopsy) is required and must be less than 6 months old.

  After SBRT is finished, eligible patients will be assigned to either:
  1. Durvalumab or
  2. placebo

  Treatments will be administered in to a vein, approximately for 1 hour.
  Eligible patients will visit the hospital once every 4 weeks for treatment for a maximum of about 24 months, undergoing tests such as physical exams, and blood and urine tests. Cancer will be measured using Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI), performed 8 weeks after treatment assignment, then every 12 weeks during treatment, then every 16 weeks until year 3, then every 6 months until their cancer gets worse. A Positron Emission Tomography (PET/CT) may also be required at screening.

  When a patient stops study treatment, they will remain in the study for long term follow-up of their disease outcome.

  The study is anticipated to continue until September 2024.
  

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  18/YH/0476

• Date of REC Opinion

  15 Feb 2019

• REC opinion

  Further Information Favourable Opinion