Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer
ACE-Lung
Phase II Study Evaluating the Combination of Cetuximab With Afatinib as First-line Treatment for Patients With EGFR Mutated Non Small Cell Lung Cancer
1 other identifier
interventional
118
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2016
Longer than P75 for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2015
CompletedFirst Posted
Study publicly available on registry
March 23, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2021
CompletedAugust 11, 2022
August 1, 2022
2.8 years
November 30, 2015
August 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Treatment Failure
9 months
Secondary Outcomes (9)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
1 month
Response Rate
9 months
Overall survival
6 months
Overall survival
9 months
Overall survival
12 months
- +4 more secondary outcomes
Study Arms (2)
Afatinib
OTHERAfatinib 40 mg/d until progression
Afatinib + cetuximab
EXPERIMENTALAfatinib 40 mg/d until progression + cetuximab 500 mg/m² every 2 weeks during 6 months (beginning at D15 at 250 mg/m²)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
Clinique de L'Europe
Amiens, France
Angers - CHU
Angers, France
Annecy - CH
Annecy, 74374, 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, 72000, 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, 58033, France
Centre Antoine Lacassagne
Nice, France
Orléans - Hôpital de la Source
Orléans, France
AP-HP Hopital Tenon - Pneumologie
Paris, 75020, France
Paris - APHP Bichat
Paris, France
Paris - APHP Saint-Louis
Paris, France
Pau - CH
Pau, 64046, France
Pontoise - CH
Pontoise, France
Centre Hospitalier
Saint-Quentin, France
Nouvel Hopital Civil - Pneumologie
Strasbourg, 63000, France
Centre Hospitalier Intercommunal
Toulon, France
HIA Saint Anne
Toulon, France
Tours - CHU
Tours, 37000, France
CH de Villefranche - Pneumologie
Villefranche, France
Villeneuve d'Ascq - Hôpital Privé
Villeneuve-d'Ascq, France
Related Publications (1)
Cortot AB, Madroszyk A, Giroux-Leprieur E, Molinier O, Quoix E, Berard 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-Line Afatinib plus Cetuximab for EGFR-Mutant Non-Small Cell Lung Cancer: Results from the Randomized Phase II IFCT-1503 ACE-Lung Study. Clin Cancer Res. 2021 Aug 1;27(15):4168-4176. doi: 10.1158/1078-0432.CCR-20-4604. Epub 2021 May 24.
PMID: 34031056RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexis CORTOT, MD, PhD
CHRU LILLE
- PRINCIPAL INVESTIGATOR
Jacques CADRANEL, MD, PhD
AP-HP Hôpital Tenon, Paris
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2015
First Posted
March 23, 2016
Study Start
May 1, 2016
Primary Completion
February 1, 2019
Study Completion
April 7, 2021
Last Updated
August 11, 2022
Record last verified: 2022-08