Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patient (FLT-THERA)

University Hospital, Angers

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer Metastatic or Non-small Cell Lung Cancer Recurrent; No EGFR Activating Mutation

Treatments: Radiation: 18F-FDG-TEP; Radiation: 18F-FLT-TEP

Study type: Interventional

Funder types: Other

Identifiers

NCT02069418

2013-001301-87 (EudraCT Number)

PHRC 2012-01

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Experimental arm

Experimental group

Description:

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.

Treatment:

Radiation: 18F-FLT-TEP

Radiation: 18F-FDG-TEP