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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 : April 24, 2020
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


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 ]


Information from the National Library of Medicine

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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
Show Show 33 study locations
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    
Other Study ID Numbers: IFCT-1503
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
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