NCT02069418: FLT-THERA

Could Positon Emission Tomography With Radiolabelled 3'-Deoxy-3'-(18)F-Fluoro-L-Thymidine be a Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patients ?

Status unknown Phase 2 Last updated 19 February 2014

What this trial tests

Phase 2 trial testing 18F-FLT-TEP in Non-small Cell Lung Cancer Metastatic or Non-small Cell Lung Cancer Recurrent in 80 participants. Status unknown.

Timeline

1 February 2014

Primary endpoint
1 June 2016

1 June 2016

Quick facts

Lead sponsor	University Hospital, Angers
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Enrollment	80
Start date	1 February 2014
Primary completion	1 June 2016
Estimated completion	1 June 2016
Sites	8 locations across France

Drugs / interventions tested

• 18F-FLT-TEP
• 18F-FDG-TEP

Conditions studied

• Non-small Cell Lung Cancer Metastatic or Non-small Cell Lung Cancer Recurrent — all drugs for Non-small Cell Lung Cancer Metastatic or Non-small Cell Lung Cancer Recurrent →
• No EGFR Activating Mutation — all drugs for No EGFR Activating Mutation →

Sponsor

University Hospital, Angers

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer Metastatic or Non-small Cell Lung Cancer Recurrent or No EGFR Activating Mutation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans
  Time frame: Six months
  The primary endpoint is the correlation between tumour response to erlotinib assessed by morphological imaging by RECIST 1.1 at Day 56 (considered the gold standard) and the change in the uptake of 18F-FLT and 18F-FDG assessed by PET before and at Day 7 after initiation of erlotinib derived from criteria PERCIST. the Kappa test will be used.

Sponsor's own description

In France, lung cancer is the leading cause of death induced by cancer. Therapeutic advances have been made in therapy of unresectable non-small cell lung cancer (NSCLC) with tyrosine kinase receptor inhibitors blocking the Epidermal Growth Factor Receptor (EGFR), as erlotinib.

This drug usually does not induce rapid shrinking of NSCLC tumour explaining why RECIST criteria are less reliable with erlotinib than cytotoxic drugs after 8 weeks of treatment.

Among patients with unresectable NSCLC, 3'-deoxy-3'-18F-fluoro-L-thymidine (18F-FLT) and 18F-2-18F-fluoro-2-deoxy-D-glucose (18F- FDG) Positron Emission Tomography (PET) has identified early responding patients and with better progression-free survival in erlotinib first line and in the second or third line.

To date, none medico-economic study has been conducted to determine if this strategy will be cost-effective.

The purpose of this study is to confirm that an early metabolic imaging with 18 F-FLT and 18FFDG PET could have theranostic issue by identifying at the fourteenth day of erlotinib (second line or more) the subjects that do not respond to erlotinib, i.e. 6 weeks prior to the morphological evaluation based on the new RECIST 1.1, that is typically done at week 8 of erlotinib treatment.

A health economics ancillary study will be achieved. Indeed, recent therapeutic improvements, in particular targeted therapies in NSCLC, have improved quality of life and life expectancy, but have also induce an important increase of the health costs. According to studies, the mean cost of the treatments of NSCLC has been increased by a factor 3 during the 10 last years. More efficient strategies that would permit to stop early with objective endpoints, expensive therapies is a main achievement in thoracic oncology.

The potential clinical impacts of this work are 1) to stop early erlotinib in non-responders and replace another treatment before a deterioration in their physical status, 2) reduce the risk of side effects and costs of unnecessary treatment and 3) to propose a customization treatment after the first line therapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Designing and Immunomodulating Multiresponsive Nanomaterial for Cancer Theranostics.
   Khan A, Dias F, Neekhra S, Singh B, et al · · 2020 · cited 8× · PMID 33585406 · DOI 10.3389/fchem.2020.631351