A Phase 2 interventional study of Afatinib and Cetuximab in Non Small Cell Lung Cancer, sponsored by Intergroupe Francophone de Cancerologie Thoracique. Completed at 33 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-11.
Sponsored by Intergroupe Francophone de Cancerologie Thoracique · Phase 2, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 118 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Intergroupe Francophone de Cancerologie Thoracique is the lead sponsor of 57 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Principal Inclusion Criteria:
Principal Exclusion Criteria:
Afatinib 40 mg/d until progression
Drug: Afatinib
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
Time to Treatment Failure
Time frame: 9 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 month
Response Rate
Time frame: 9 months
Overall survival
Time frame: 6 months
Overall survival
Time frame: 9 months
Overall survival
Time frame: 12 months
Progression-Free Survival
Time frame: 6 months
Progression-Free Survival
Time frame: 9 months
Progression-Free Survival
Time frame: 12 months
Progression-Free Survival
Time frame: 18 months
Plan to share: Undecided
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Intergroupe Francophone de Cancerologie Thoracique