Pembrolizumab and Palliative Radiotherapy in Lung

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT02587455
Phase
PHASE1
Status
Completed

Conditions

  • Thoracic Tumours

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab - Trial Treatment
  • Radiotherapy — RADIATION
    Radiotherapy - Standard Treatment

Study Details

Lung cancer is the second most common cancer in the UK with around 43,500 new patients diagnosed each year. About 69% of patients are diagnosed with advanced stage disease and at present these patients would be expected to survive for less than 12 months. These statistics therefore show the need for the development of new effective drugs in the treatment of advanced Lung cancer. Recent trial results have shown the efficacy of immunotherapy in treating several types of tumours including lung cancer. These tumours are known to express a high level of a glycoprotein called PDL1 which is a component of the PD1 pathway. In cancer the PD1 pathway can be hijacked by tumours leading to the immune system being suppressed. The aim of the new drug Pembrolizumab is to restart the PD1 pathway and use the immune system to help fight the cancer cells. Radiotherapy has also been shown to cause cancer to increase production of the proteins that can block the immune system. Therefore it has been proposed that combine of new immunotherapy agent such as pembrolizumab and radiotherapy in the treatment of lung cancer will allow more cancer cells to be killed through the immune system. The purpose of this study is to see if pembrolizumab can safety be combined with standard palliative radiotherapy in patients with lung cancer. In addition once the patients have completed their course of radiotherapy they will remain on pembrolizumab alone and the study will look at how well this treatment regimen can control the growth of the cancer.

Key Dates

Start date
Jun 24, 2016
Status verified
Apr 2026
Primary completion
Aug 20, 2021
Completion
Aug 20, 2021

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Low Dose Radiotherapy Arm
    Pembrolizumab and radiotherapy
  • Experimental: High Dose Radiotherapy Arm
    Pembrolizumab and radiotherapy

Primary Outcome Measure

Toxicity Rate of Dose Limiting Toxicities (DLTs) Assessed by CTCAEv4 [ Time Frame: 2 months following the final fraction of RT ]

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