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

Phase 2

Completed

• Conditions: Non-Small Cell Carcinoma of Lung, TNM Stage 4

• Registration Number: NCT03406468
• Lead Sponsor: Maastricht Radiation Oncology

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.

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 Timeline

• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-15
• Study First Posted: 2018-01-23
• Study Start: 2019-07-15
• Primary Completion: 2022-08-01
• Study Completion: 2023-03-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression free survival	3 months after end of radiotherapy	Progression free survival

Secondary Outcome Measures

Name	Time	Method
Remission rate irradiated lesion	3 months after end of radiotherapy	Remission rate (RECIST 1.0) of the irradiated lesion
Remission rate non-irradiated lesion(s)	3 months after end of radiotherapy	Remission rate (RECIST 1.0) of the non-irradiated lesion(s)
Toxicity	3 months after end of radiotherapy	Toxicity evaluation CTCAE4.0

Trial Locations

Locations (3)

Zuyderland Hospital; 🇳🇱 Heerlen, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

MAATRO clinic; 🇳🇱 Maastricht, Netherlands