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NCT02587455: PEAR

Pembrolizumab and Palliative Radiotherapy in Lung

Completed Phase 1 Last updated 14 May 2024
What this trial tests

Phase 1 trial testing Pembrolizumab in Thoracic Tumours in 24 participants. Completed in 20 August 2021.

Timeline
24 June 2016
Primary endpoint
20 August 2021
20 August 2021

Quick facts

Lead sponsorRoyal Marsden NHS Foundation Trust
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeother
Enrollment24
Start date24 June 2016
Primary completion20 August 2021
Estimated completion20 August 2021
Sites2 locations across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Royal Marsden NHS Foundation Trust

Who can join

18 and older, any sex, with Thoracic Tumours. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Abscopal effect of radiotherapy combined with immune checkpoint inhibitors.
    Liu Y, Dong Y, Kong L, Shi F, et al · · 2018 · cited 337× · PMID 30115069 · DOI 10.1186/s13045-018-0647-8
  2. Current clinical trials testing the combination of immunotherapy with radiotherapy.
    Kang J, Demaria S, Formenti S. · · 2016 · cited 293× · PMID 27660705 · DOI 10.1186/s40425-016-0156-7
  3. Combination of immunotherapy with chemotherapy and radiotherapy in lung cancer: is this the beginning of the end for cancer?
    Lazzari C, Karachaliou N, Bulotta A, Viganó M, et al · · 2018 · cited 91× · PMID 29662546 · DOI 10.1177/1758835918762094
  4. Trial Watch: Immunotherapy plus radiation therapy for oncological indications.
    Vacchelli E, Bloy N, Aranda F, Buqué A, et al · · 2016 · cited 61× · PMID 27757313 · DOI 10.1080/2162402x.2016.1214790
  5. Proton beam therapy and immunotherapy: an emerging partnership for immune activation in non-small cell lung cancer.
    Lee HJ, Zeng J, Rengan R. · · 2018 · cited 32× · PMID 29876317 · DOI 10.21037/tlcr.2018.03.28
  6. Synergistic effect of immunotherapy and radiotherapy in non-small cell lung cancer: current clinical trials and prospective challenges.
    Yang H, Jin T, Li M, Xue J, et al · · 2019 · cited 26× · PMID 35694698 · DOI 10.1093/pcmedi/pbz004
  7. Combination therapy with PD-1/PD-L1 blockade: An overview of ongoing clinical trials.
    Johnson CB, Win SY. · · 2018 · cited 26× · PMID 29632719 · DOI 10.1080/2162402x.2017.1408744
  8. Abscopal Effects in Metastatic Cancer: Is a Predictive Approach Possible to Improve Individual Outcomes?
    Link B, Torres Crigna A, Hölzel M, Giordano FA, et al · · 2021 · cited 20× · PMID 34768644 · DOI 10.3390/jcm10215124

Verify or expand the search:

Other trials of Pembrolizumab

Trials testing the same drug.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02587455.

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