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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

Organizational Data

DRKS-ID:
DRKS00013531
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2017-12-04
Last update in DRKS:
2018-12-06
Registration type:
Prospective

Acronym/abbreviation of the study

RadImmun-NSCLC

URL of the study

No Entry

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.

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.

Health condition or problem studied

ICD10:
C34 - Malignant neoplasm of bronchus and lung
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Radiation therapy, immunotherapy with approved checkpoint inhibitors, tumor assessment by imaging, collection of blood samples (and biopsy material), evaluation of results

Endpoints

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)
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

Study Design

Purpose:
Treatment
Allocation:
N/A (single arm study)
Control:
  • Uncontrolled/single arm
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Single (group)
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik für Strahlenheilkunde Freiburg im Breisgau

Recruitment period and number of participants

Planned study start date:
2017-12-18
Actual study start date:
2018-03-22
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
50
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
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.

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.

Addresses

Primary Sponsor

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Prof. Dr. med. Anca Ligia Grosu
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Prof. Dr. med. Anca Ligia Grosu
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
0761 270 94610
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Klinik für Strahlenheilkunde
Dr. med. Ilinca Popp
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
+49 761 270-94610
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Prof. Dr. med. Anca Ligia Grosu
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
0761 270 94610
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
Robert-Koch-Str. 3
79106 Freiburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2017-06-09
Ethics committee number:
297/17
Vote of the Ethics Committee:
Approved
Date of the vote:
2017-11-16

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry