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Re-Induction After Initial Response With Immune Therapy With Radiotherapy in Lung Cancer

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ClinicalTrials.gov Identifier: NCT03406468
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
The Netherlands Cancer Institute
Maastricht University Medical Center
Zuyderland Medical Centre
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Study Description
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Brief Summary:
Radiotherapy in combination with different forms of immune therapy improved consistently local tumor control and very interestingly, lead to better systemic tumor control and the induction of specific anti-cancer immunity with a memory effect. In small series, it has been shown that a new long-lasting remission can be induced by irradiating one tumor site in patients who showed cancer progression after an initial response to immune therapy. In these series, the original immune therapy was continued and the treatment was very well tolerated. In this study the progression-free survival after radiotherapy to a single lesion will be investigated in patients with stage IV non-small cell lung cancer (NSCLC), who have at least achieved stable disease with immune therapy alone or concurrent immune therapy and chemotherapy.

Condition or disease Intervention/treatment Phase
Non-Small Cell Carcinoma of Lung, TNM Stage 4 Radiation: Radiotherapy Phase 2

Detailed Description:

Radiation has consistently been shown to activate key elements of the immune system. Radiotherapy in combination with different forms of immune therapy such as anti-PD-(L)1, anti-CTLA4,immunocytokines, dendritic cell vaccination and Toll-like receptor agonists improved consistently local tumor control and very interestingly, lead to better systemic tumor control (the "abscopal" effect) and the induction of specific anti-cancer immunity with a memory effect. Moreover, as PD1/PD-L1 is upregulated by radiation and radiation can overcome resistance for PD-(L)1 blockage, their combination is logical.

In small series, it has been shown that a new long-lasting remission can be induced by irradiating one tumor site in patients who showed cancer progression after an initial response to immune therapy. In these series, the original immune therapy was continued and the treatment was very well tolerated. In this study the progression-free survival after radiotherapy to a single lesion will be investigated in patients with stage IV non-small cell lung cancer (NSCLC), who have at least achieved stable disease with immune therapy alone or concurrent immune therapy and chemotherapy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Given the objective of this phase II trial and the limited number of patients, no formal statistical analyses are planned. Analysis will be limited to presentation of frequencies and proportions and the report of descriptive statistics (e.g. mean, median and/or range) in tabulated form.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Re-Induction of a Systemic Immune Response After Initial Response With Immune Therapy With Radiotherapy in Metastatic or Locally Recurrent Lung Cancer
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Radiotherapy
Patients continue the same immune therapy they already received and get radiotherapy to one lesion. The lesion may or may not be symptomatic. The preferred radiotherapy dose is 24 Gy in 3 fractions (dosage on the 10 Gy isodose is allowed), but other fractionation schedules (e.g. 30 Gy/ 10 fractions, 20 Gy/ 5 fractions, 20-24 Gy / 1 fraction for SRS (stereotactic radiosurgery)) are allowed if these are standard for a certain location or palliative indication in the body.
 Radiation: Radiotherapy
Patients continue the same immune therapy they already received and get radiotherapy to one lesion. The lesion may or may not be symptomatic. The preferred radiotherapy dose is 24 Gy in 3 fractions (dosage on the 10 Gy isodose is allowed), but other fractionation schedules (e.g. 30 Gy/ 10 fractions, 20 Gy/ 5 fractions, 20-24 Gy / 1 fraction for SRS (stereotactic radiosurgery)) are allowed if these are standard for a certain location or palliative indication in the body.


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 3 months after end of radiotherapy ]
    Progression free survival


Secondary Outcome Measures :
  1. Remission rate irradiated lesion [ Time Frame: 3 months after end of radiotherapy ]
    Remission rate (RECIST 1.0) of the irradiated lesion

  2. Remission rate non-irradiated lesion(s) [ Time Frame: 3 months after end of radiotherapy ]
    Remission rate (RECIST 1.0) of the non-irradiated lesion(s)

  3. Toxicity [ Time Frame: 3 months after end of radiotherapy ]
    Toxicity evaluation CTCAE4.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage IV non-small cell lung cancer
  • Initially a Complete Remission, Partial Remission or Stable Disease under immune therapy alone or concurrent immune therapy and chemotherapy and now progressive disease
  • Able to continue the immune therapy

Exclusion Criteria:

  • Not able to continue the already initiated immune therapy
  • Patients with any grade 3 toxocity
  • Patients in whom radiotherapy cannot be delivered, according to the radiation oncologist at the multi-disciplinary patient discussion
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406468


Contacts
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Contact: Chantal Overhof-Wedick 0031 88 44 55 686 chantal.overhof@maastro.nl

Locations
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Netherlands
Zuyderland Hospital Recruiting
Heerlen, Netherlands, 6419 PC
Contact: Gerben Bootsma, PhD    0031 45 459 97 06    gerben.bootsma@zuyderland.nl   
Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6202 AZ
Contact: Anne-Marie Dingemans, MD, PhD    0031 43 387 55 00    a.dingemans@mumc.nl   
Contact: Lizza Hendriks, PhD    0031 43 387 55 00    lizza.hendriks@mumc.nl   
MAATRO clinic Recruiting
Maastricht, Netherlands, 6229 ET
Contact: Chantal Overhof-Wedick    0031 88 44 55 686    chantal.overhof@maastro.nl   
Principal Investigator: Dirk De Ruysscher, MD, PhD         
Sponsors and Collaborators
Maastricht Radiation Oncology
The Netherlands Cancer Institute
Maastricht University Medical Center
Zuyderland Medical Centre
Investigators
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Principal Investigator: Dirk De Ruysscher, MD, PhD Maastro Clinic, The Netherlands
More Information
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Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT03406468    
Other Study ID Numbers: Re-Induction
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht Radiation Oncology:
non small cell lung cancer
immune therapy
radiotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms