Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

— ACE-Lung  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716311
• Other study ID #: IFCT-1503
• Status: Completed
• Phase: Phase 2
• Start date: May 2016
• Est. completion date: April 7, 2021

Study information

• Verified date: August 2022
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 7, 2021
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Afatinib

• Cetuximab

Locations

Country	Name	City	State
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	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	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	Centre Antoine Lacassagne	Nice
France	Orléans - Hôpital de la Source	Orléans
France	AP-HP Hopital Tenon - Pneumologie	Paris
France	Paris - APHP Bichat	Paris
France	Paris - APHP Saint-Louis	Paris
France	Pau - CH	Pau
France	Pontoise - CH	Pontoise
France	Centre Hospitalier	Saint-Quentin
France	Nouvel Hopital Civil - Pneumologie	Strasbourg
France	Centre Hospitalier Intercommunal	Toulon
France	HIA Saint Anne	Toulon
France	Tours - CHU	Tours
France	CH de Villefranche - Pneumologie	Villefranche
France	Villeneuve d'Ascq - Hôpital Privé	Villeneuve-d'Ascq

Sponsors (1)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique

Country where clinical trial is conducted

France, 

References & Publications (1)

Cortot AB, Madroszyk A, Giroux-Leprieur E, Molinier O, Quoix E, Bérard H, Otto J, Rault I, Moro-Sibilot D, Raimbourg J, Amour E, Morin F, Hureaux J, Moreau L, Debieuvre D, Morel H, Renault A, Pichon E, Huret B, Charpentier S, Denis MG, Cadranel J. First-L — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Treatment Failure		9 months
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		1 month
Secondary	Response Rate		9 months
Secondary	Overall survival		6 months
Secondary	Overall survival		9 months
Secondary	Overall survival		12 months
Secondary	Progression-Free Survival		6 months
Secondary	Progression-Free Survival		9 months
Secondary	Progression-Free Survival		12 months
Secondary	Progression-Free Survival		18 months

External Links

•   IFCT website