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Miss Erin Peat


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Be Part of Research - Trial Details - PARIS-Pembrolizumab in combination with radiotherapy in locally advanced non-small cell lung cancer (NSCLC)
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PARIS-Pembrolizumab in combination with radiotherapy in locally advanced non-small cell lung cancer (NSCLC)

Stopped

Open to: All Genders

Age: Adult

Leeds Manchester Surrey

Medical Conditions

Lung Cancer

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


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Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Aug 2017 01 Feb 2020

Interventional

Intervention Type : Other
Intervention Description : Participants receive the first dose of pembrolizumab two weeks before the start of radiotherapy. Pembrolizumab is subsequently delivered every three weeks, starting on the first day of radiotherapy and are continued after completion of radiotherapy for up to 12 months. Participants receive radiotherapy for up to six and a half weeks.

As this combination of treatment has not been given before, participants are registered initially into a dose finding phase where dose limiting toxicities (DLTs) is monitored during and for 12 weeks after completion of combined pembrolizumab and thoracic radiotherapy at each dose level in order to confirm the recommended phase II dose. Participants are given a different dose of pembrolizumab treatment depending on the group or ‘cohort’ they are recruited into.

The starting dose of pembrolizumab for the first patients are 200 mg (dose level 1). This dose may be reduced to a dose of 100 mg (dose level -1) if unacceptable numbers of dose limiting toxicities are experienced at dose level 1. A maximum of 12 participants are treated in the dose finding part of the study aiming to establish the recommended phase II dose (RP2D).

Once the recommended phase II dose is found, an expanded cohort of 13 participants are treated at this dose of pembrolizumab to obtain further safety data.

During radiotherapy treatment the patient are seen weekly for follow-up.

After completion of combination pembrolizumab and radiotherapy treatment, patient visits are scheduled at these time-points:1. Weekly visits until toxicity resolved to grade 0-1 after radiotherapy. Patients in the dose finding cohort will also be seen weekly to week four regardless of toxicity.2. Patients on maintenance Pembrolizumab: Three weekly visit up to 12 months3. Patients not on maintenance Pembrolizumab: Monthly visits for up to four months post RT and then at months six, nine and 12.4. CT scan assessment within a month of completing RT, three, six and 12 months (following RT)Thereafter, follow-up visits are scheduled according to host institution protocol.

All participants, including those withdrawn due to toxicity, are followed up for adverse reactions and serious adverse reactions until death, withdrawal of consent, or the end of the study (whichever occurs first).




You can take part if:



You may not be able to take part if:


1. Mixed non-small cell and small cell tumours2. 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 pneumonitis5. 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 hyperthyroidism8. 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.11. Chronic GI disease likely to interfere with protocol treatment. 12. Testing positive for human immunodeficiency virus, active hepatitis B or C infection.13. Treatment with live vaccine within 30 days prior to the first dose of trial treatment. 14. Patients of reproductive potential who are unable to comply with effective contraception if sexually active during the study and for up to 120 days after the last dose of Pembrolizumab 15. Women who are pregnant or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test 16. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St James’s University Hospital
    Beckett Street
    Leeds
    LS9 7TF
  • The Christie Hospital
    Wilmslow Road Withington
    Manchester
    M20 4BX
  • Royal Marsden Hospital
    Downs Road Sutton
    Surrey
    SM2 5PT

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Miss Erin Peat



The study is sponsored by The Christie NHS Foundation Trust and funded by Cancer Research UK.



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Read full details for Trial ID: ISRCTN14634058

Or CPMS 34452

Last updated 21 June 2019

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