Clinical Trials Logo

Clinical Trial Summary

This will be a phase II trial testing if the combination of stereotactic ablative body radiotherapy (SABR) and L19-IL2 improve the progression-free survival in patients with limited metastatic non-small cell lung cancer (NSCLC). The trial consists of one cohort with two arms; C-arm and an E-arm. Patients with oligometastatic disease will receive SABR to minimal 1 and max all metastatic sites (max 5 sites irradiated) and patients with diffuse metastatic lesions (6 to max 10) will receive radiotherapy to max 5 sites. In the experimental arm, immunotherapy will be given after irradiation.


Clinical Trial Description

IMMUNOSABR will include 126 patients. In this single-stage controlled randomised open-label phase II trial, we aim to demonstrate an absolute increase in progression-free survival (primary endpoint). PFS will be determined as the time between randomisation and disease progression, according to RECIST 1.1, death due to any cause or last patient contact alive and progression-free. Patients will be randomized between control (no immunocytokine) and experimental arms (with immunocytokine L19-IL2) in a 1:1 ratio. The accrual period will be 29 months (or 2.41 years), and the minimum follow-up will be 18 months (or 1.5 years), making the total study duration 47 months. Comparison between control and experimental arms will be made using the Log-Rank statistic. This test for superiority will be one-sided with the desired type I error of 0.10 and power of 0.90. Patients enrolled in the trial will be randomised into the control arm (C-arm) or experimental arm (E-arm). - C-arm: Standard of Care (SOC) according to the local and national guidelines: (wait and see or surgery and/or chemotherapy and/or standard (symptomatic) radiotherapy and/or SABR, oligometastatic disease. - E-arm: SABR (oligometastatic disease) or radiotherapy (diffuse disease) + L19-IL2 up to 6 cycles (+ aPD(L)1 if SOC) The expected 1.5-year PFS is 15% in the C-arm and 35% in the E-arm. A sample size of 116 patients (58 patients per treatment arm) is needed to show this difference of 20% in PFS, using a logrank test with a two-sided alpha of 0.05 and power of 85%. Patients will be evenly divided over the two arms. Assuming a drop-out rate of 10%, a total of 126 patients (63 per arm) need to be included. Primary objective The main objective of the trial is to test if the activity of the combination of (SAB)R and L19-IL2 in patients with metastatic NSCLC will result in improved progression-free survival (PFS) compared to the SOC. Secondary Objectives - Assessment of the PFS of the patient cohort, at 5 years after randomisation. - Assessment of the overall survival of the patient cohort, at 5 years after randomisation. - To assess the toxicity of this treatment schedule; - To assess Quality of Life (QoL); - To assess the occurrence of an Out of Field Radio-Immune (OFRI) response / abscopal effect using imaging; - To assess the occurrence of an In Field Radio-Immune (IFRI) response using imaging; - To perform correlative biomarker studies related to treatment response. Exploratory endpoints: - Correlative biomarker studies: - Tumour tissue: e.g EDB expression, non-synonymous mutations, immune monitoring; - Blood: e.g. EDB expression, cfDNA, and immune monitoring; - Radiomics on CT and if available MRI; - Faeces: diversity in microbiota. - iRECIST - Tumour grow kinetics ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03705403
Study type Interventional
Source Maastricht University
Contact ImmunoSABR Maastricht University
Phone +31(0)43 3883549
Email immunosabr@maastrichtuniversity.nl
Status Recruiting
Phase Phase 2
Start date April 4, 2019
Completion date December 1, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05543330 - A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC Phase 1/Phase 2
Recruiting NCT04106180 - SBRT in Combination With Sintilimab and GM-CSF for the Treatment of Advanced NSCLC Phase 2
Recruiting NCT05215548 - Primary Tumor Resection With EGFR TKI for Stage IV NSCLC Phase 2
Recruiting NCT04042558 - A Study Evaluating Platinum-Pemetrexed-Atezolizumab (+/-Bevacizumab) for Patients With Stage IIIB/IV Non-squamous Non-small Cell Lung Cancer With EGFR Mutations, ALK Rearrangement or ROS1 Fusion Progressing After Targeted Therapies Phase 2
Completed NCT04507217 - Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC Phase 2
Recruiting NCT04467801 - Ipatasertib and Docetaxel in Metastatic NSCLC Patients Who Have Failed 1st Line Immunotherapy Phase 2
Active, not recruiting NCT04027647 - Phase 2 Study of Dacomitinib in NSCLC Phase 2
Recruiting NCT04768491 - Dacomitinib Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced NSCLC
Not yet recruiting NCT04492969 - Prospective Observation of Failure Patterns in NSCLC Treated With ICIs
Recruiting NCT04116918 - Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative NSCLC
Terminated NCT03411473 - Study of AGEN1884 With Pembrolizumab in 1L NSCLC Phase 2
Recruiting NCT03564197 - 18F-PD-L1 PET/CT in Nivolumab Treated Patients With NSCLC N/A
Not yet recruiting NCT06219317 - Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC Phase 2
Not yet recruiting NCT04604470 - Trial-specific Patient Decision Aid (tPDA) of the ImmunoSABR Phase 2
Recruiting NCT05132218 - Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
Not yet recruiting NCT04136535 - Pemetrexed and Carboplatin With or Without Anlotinib Hydrochloride for Osimertinib-resistant Non-squamous NSCLC Phase 2
Completed NCT03184571 - Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC Phase 2
Recruiting NCT04549428 - Atezolizumab Plus 8 Gy Single-fraction Radiotherapy for Advanced Oligoprogressive NSCLC Phase 2
Recruiting NCT03647956 - Atezolizumab in Combination With Bevacizumab, Carboplatin and Pemetrexed for EGFR-mutant Metastatic NSCLC Patients After Failure of EGFR Tyrosine Kinase Inhibitors Phase 2
Recruiting NCT04180501 - SRS Sequential Sindilimab in Brain Metastasis of NSLSC Phase 2