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Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer (ACE-Lung)

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ClinicalTrials.gov Identifier: NCT02716311
Recruitment Status : Active, not recruiting
First Posted : March 23, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

Brief Summary:

Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved in several phase III trials with gefitinib, erlotinib or afatinib.

Nevertheless, all patients will progress after 9 to 12 months of treatment due to the appearance of a treatment resistance.

Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that afatinib delay the appearance of resistance.

Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The hypothesis of this study is that the combination between cetuximab and afatinib will permit to delay or decrease the appearance of resistances.


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Afatinib Drug: Cetuximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Combination of Cetuximab With Afatinib as First-line Treatment for Patients With EGFR Mutated Non Small Cell Lung Cancer
Actual Study Start Date : May 2016
Actual Primary Completion Date : February 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Afatinib
Afatinib 40 mg/d until progression
Drug: Afatinib
Experimental: Afatinib + cetuximab
Afatinib 40 mg/d until progression + cetuximab 500 mg/m² every 2 weeks during 6 months (beginning at D15 at 250 mg/m²)
Drug: Afatinib
Drug: Cetuximab



Primary Outcome Measures :
  1. Time to Treatment Failure [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 month ]
  2. Response Rate [ Time Frame: 9 months ]
  3. Overall survival [ Time Frame: 6 months ]
  4. Overall survival [ Time Frame: 9 months ]
  5. Overall survival [ Time Frame: 12 months ]
  6. Progression-Free Survival [ Time Frame: 6 months ]
  7. Progression-Free Survival [ Time Frame: 9 months ]
  8. Progression-Free Survival [ Time Frame: 12 months ]
  9. Progression-Free Survival [ Time Frame: 18 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Principal Inclusion Criteria:

  • Stage III or IV NSCLC, non irradiable non operable
  • Non squamous NSCLC histologically or cytologically confirmed
  • No previous treatment of NSCLC
  • EGFR mutation (exon 19 deletion, L858R mutation, G719X , L861Q or S768I mutations or exon 19 insertion)
  • Presence of at least one lesion that can be measured
  • PS 0 or 1

Principal Exclusion Criteria:

  • Symptomatic brain metastasis or requiring immediate radiotherapy
  • T790M mutation or exon 20 insertion
  • Radiotherapy less than 2 weeks prior randomization including symptomatic radiotherapy
  • Interstitial pneumopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716311


Locations
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France
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
Clinique de L'Europe
Amiens, France
Angers - CHU
Angers, France
Annecy - CH
Annecy, France, 74374
Bordeaux - Institut Bergonié
Bordeaux, France
Bordeaux - Polyclinique Nord
Bordeaux, France
Boulogne - Ambroise Paré
Boulogne-Billancourt, France
Clermont-Ferrand - CHU
Clermont-Ferrand, France
CH
Colmar, France
CHRU Grenoble
Grenoble, France
Centre Hospitalier - Pneumologie
Le Mans, France, 72000
CHRU de Lille
Lille, France
Lille - Polyclinique de la Louvière
Lille, France
Lyon - Hôpital Privé Jean Mermoz
Lyon, France
Institut Paoli Calmette
Marseille, France
Montpellier - GCS Centre de Cancérologie du Grand Montpellier
Montpellier, France
CH de Mulhouse
Mulhouse, France
Nantes - ICO René Gauducheau
Nantes, France
Nevers - CH
Nevers, France, 58033
Centre Antoine Lacassagne
Nice, France
Orléans - Hôpital de la Source
Orléans, France
AP-HP Hopital Tenon - Pneumologie
Paris, France, 75020
Paris - APHP Bichat
Paris, France
Paris - APHP Saint-Louis
Paris, France
Pau - CH
Pau, France, 64046
Pontoise - CH
Pontoise, France
Centre Hospitalier
Saint-Quentin, France
Nouvel Hopital Civil - Pneumologie
Strasbourg, France, 63000
Centre Hospitalier Intercommunal
Toulon, France
HIA Saint Anne
Toulon, France
Tours - CHU
Tours, France, 37000
CH de Villefranche - Pneumologie
Villefranche, France
Villeneuve d'Ascq - Hôpital Privé
Villeneuve-d'Ascq, France
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Investigators
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Principal Investigator: Alexis CORTOT, MD, PhD CHRU, Lille
Principal Investigator: Jacques CADRANEL, MD, PhD AP-HP Hôpital Tenon, Paris

Additional Information:
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Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT02716311     History of Changes
Other Study ID Numbers: IFCT-1503
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
EGFR
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cetuximab
Afatinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action