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

NCT02069418 | Unknown Phase 2

• 2 other identifiers: PHRC 2012-012013-001301-87
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 8

Brief 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

Outcome Measures

Primary Outcomes (1)

• Early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans

  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.

  Six months

Secondary Outcomes (1)

• Economic study of the early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans

  Six months

Study Arms (1)

Experimental 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.

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

Interventions

18F-FLT-TEP RADIATION

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.

Experimental arm

18F-FDG-TEP RADIATION

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.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead
• University Hospital, Tours: collaborator
• Army Hospital, Percy: collaborator
• Créteil Hospital: collaborator
• University Hospital, Rouen: collaborator
• Central Hospital, Nancy, France: collaborator
• University Hospital, Toulouse: collaborator
• University Hospital, Bordeaux: collaborator

Study Sites (8)

University Hospital, Bordeaux

Bordeaux, Gironde, 33000, France

Location

Army Hospital, Percy

Percy, Haut de Seine, 92140, France

Location

University Hospital, Toulouse

Toulouse, Haute Garonne, 31000, France

Location

University Hospital, Tours

Tours, Indre et Loire, 37000, France

Location

University Hospital, Angers

Angers, Maine et Loire, 49933, France

Location

University Hospital, Nancy

Nancy, Meurthe et Moselle, 54000, France

Location

University Hospital, Rouen

Rouen, Seine maritime, 76000, France

Location

Hospital, Créteil

Créteil, Val de Marne, 94000, France

Location

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Study Officials

• José HUREAUX, MD, PhD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

• Olivier COUTURIER, MD, PhD

  University Hospital, Angers

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 24, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 24, 2014

Record last verified: 2014-02

Locations

FR (8)