Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patient

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.

Conditions

• Non-small Cell Lung Cancer Metastatic or Non-small Cell Lung Cancer Recurrent
• No EGFR Activating Mutation

Interventions

RADIATION

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.

RADIATION

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.

Sponsors & Collaborators

• University Hospital, Tours

  collaborator OTHER

• Army Hospital, Percy

  collaborator UNKNOWN

• Créteil Hospital

  collaborator OTHER

• University Hospital, Rouen

  collaborator OTHER

• Central Hospital, Nancy, France

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• University Hospital, Angers

  lead OTHER_GOV

Principal Investigators

• José HUREAUX, MD, PhD · University Hospital, Angers

• Olivier COUTURIER, MD, PhD · University Hospital, Angers

Study Design

Allocation

NA

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2016-06-30

Completion

2016-06-30

Countries

• France

Study Locations