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 : January 18, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small Cell Carcinoma of Lung, TNM Stage 4 | Radiation: Radiotherapy | Phase 2 |
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 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 |

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. |
- Progression free survival [ Time Frame: 3 months after end of radiotherapy ]Progression free survival
- Remission rate irradiated lesion [ Time Frame: 3 months after end of radiotherapy ]Remission rate (RECIST 1.0) of the irradiated lesion
- 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)
- Toxicity [ Time Frame: 3 months after end of radiotherapy ]Toxicity evaluation CTCAE4.0

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

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
Contact: Chantal Overhof-Wedick | 0031 88 44 55 686 | chantal.overhof@maastro.nl |
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 |
Principal Investigator: | Dirk De Ruysscher, MD, PhD | Maastro Clinic, The Netherlands |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
non small cell lung cancer immune therapy radiotherapy |
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 |