Trial-specific Patient Decision Aid (tPDA) of the ImmunoSABR Phase 2 — I-SABR2_PDA  

Lung Cancer Clinical Trial

Official title: Trial-specific Patient Decision Aid (tPDA) of the ImmunoSABR Phase 2

Status Not yet recruiting

Clinical Trial Summary

This is a trial-specific (NCT03705403) decision aid (tPDA) for stage IV NSCLC patients that might want to participate.

We want to investigate if a tPDA would be (significantly) helpful for these patients in making a decision.

ImmunoSABR has a complex study design, we expect that the patients get a better overview of the trial via the tPDA because you can bring multiple tools together. (text, video, questions, pictures, timelines, etc.)

Clinical Trial Description

A lung cancer patient might want to take part in the ImmunoSABR phase 2 trial (NCT03705403). Before they can decide, it is important that the patients understand why the research is being done and what it would involve for them.

This tPDA will give information about this trial via text, small movies, quiz and preferences. In the end, the patient will receive an overview of their choices.

Detailed Description ImmunoSABR:

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 ;

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Metastatic Cancer
• Non Small Cell Lung Cancer
• NSCLC Stage IV

• NCT number: NCT04604470
• Study type: Observational
• Source: Maastricht University
• Contact: Iva Halilaj, Msc
• Phone: +31 (0)43 3883549
• Email: i.halilaj@maastrichtuniversity.nl
• Status: Not yet recruiting
• Start date: October 20, 2020
• Completion date: December 2023