Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03406468
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : April 14, 2021
Sponsor:
Collaborators:
The Netherlands Cancer Institute
Maastricht University Medical Center
Zuyderland Medical Centre
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Chantal Overhof-Wedick 0031 88 44 55 686 chantal.overhof@maastro.nl

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Dirk De Ruysscher, MD, PhD Maastro Clinic, The Netherlands
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
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