Overview

This trial is active, not recruiting.

Conditions non-small cell lung cancer metastatic or non-small cell lung cancer recurrent, no egfr activating mutation
Treatments 18f-flt-tep, 18f-fdg-tep
Phase phase 2
Sponsor University Hospital, Angers
Collaborator University Hospital, Tours
Start date February 2014
End date June 2016
Trial size 80 participants
Trial identifier NCT02069418, 2013-001301-87, PHRC 2012-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
All patients will be in the same arm. Patients are going to have two 18F-FLT-TEP and two 18F-FDG-TEP : the first ones during the two weeks before the beginning of erlotinib and the second ones will occur during the second week after the initiation of erlotinib. The order of TEP is not definite : 18F-FLT-TEP may be planned first or reciprocally. A period of 48 hours must separate two TEP.
18f-flt-tep
Patients are going to have two 18F-FLT-TEP : one during the two weeks before the beginning of erlotinib and the second one will occur during the second week after the initiation of erlotinib.
18f-fdg-tep
Patients are going to have two 18F-FDG-TEP : one during the two weeks before the beginning of erlotinib and the second one will occur during the second week after the initiation of erlotinib.

Primary Outcomes

Measure
Early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans
time frame: Six months

Secondary Outcomes

Measure
Economic study of the early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans
time frame: Six months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - age over superior to 18 - NSCLC proved by a histological biopsy - EGFR mutation status known with no activating EGFR mutation - indication of erlotinib therapy after at least one previous therapy - patients who have signed an informed consent to participate in this study - life expectancy exceeding 12 weeks - WHO activity score between 0 and 2. Exclusion Criteria: - contraindication for the initiation of erlotinib - refusal to sign the consent - progressive inflammatory disease - infection with the HIV virus - other malignant disease - life expectancy less than 12 weeks - major adults protected by French law

Additional Information

Official title 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 ?
Principal investigator José HUREAUX, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by University Hospital, Angers.