Trial document




drksid header

  DRKS00013531

Trial Description

start of 1:1-Block title

Title

Evaluation of Systemic Effects of Combined Palliative Radiation Therapy and Immunotherapy in Patients with Metastatic Non-Small Cell Lung Cancer after Insufficient Response to Immune Checkpoint Blockade

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

RadImmun-NSCLC

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

There is data showing that radiation therapy may not only kill tumor cells, but also stimulate the body's immune system, so that it can "attack" the tumor. This reaction could be enhanced by the combination with the so-called immune therapy (such as Nivolumab). In this study we aim to evaluate the tumor response after such a combination therapy and to pay special attention to the tumor sites which were not irradiated.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Radiation therapy appears to trigger a local and even systemic immune response through immunogenic tumor cell death. The combination between radiation- and immunotherapy may further lead to better tumor control. Our primary objective is to investigate the clinical efficacy of combining immunotherapy and radiotherapy and to describe possible abscopal effects.
An amendement to the first protocol was approved by the Ethik-Comission of the Albert-Ludwigs-Universität Freiburg on the 30th October 2018 (ID 297/17). Within this Amendment we expanded the protocol to comprise all approved checkpoint-inhibitors and changed the title of the trial.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00013531
  •   2017/12/04
  •   [---]*
  •   yes
  •   Approved
  •   297/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Radiation therapy, immunotherapy with approved checkpoint inhibitors, tumor assessment by imaging, collection of blood samples (and biopsy material), evaluation of results
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Overall Response Rate (ORR) according to RECIST 1.1 and irRC; Best response of non-target index-lesions and thus evaluation of systemic immune-related effects (abscopal effects)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Progression-free survival; Acute and late toxicity induced by the combined therapy; Local control achieved by radiation therapy; Overall survival; Quality of life as measured by means of EORTC QLQ-C30 questionnaire

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/03/22
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients with metastatic NSCLC and progressive disease; At least three lesions measurable by computed tomography scan or magnetic resonance imaging; Patients presenting the indication for radiation therapy, with a minimum of 2 metastases not amenable to radiation therapy; Mixed or partial response under immunotherapy with checkpoint inhibitors; Minimum life expectancy of 3 months; Adequate bone marrow function; Adequate liver function; Written informed consent must be obtained according to ICH/GCP, and national/local regulations; Adequate birth control measures during the study treatment period.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Age < 18 years; Central nervous system metastases mandating active treatment; ECOG performance status > 2; Female subjects who are pregnant; Patients under chronic treatment with systemic immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 1 week prior starting the study treatment; Patients with active, known, or suspected autoimmune disease; Other active or significantly bone marrow-suppressing malignancy or therapy; Known activating EGFR Mutation or a known ALK Translocation; Patients with previous malignancies; Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  Anca Ligia  Grosu 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  Anca Ligia  Grosu 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Strahlenheilkunde
    • Ms.  Dr. med.  Ilinca  Popp 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.