Non Small Cell Lung Cancer
Conditions
Keywords
EGFR, Lung Cancer
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.
Interventions
DRUGAfatinib
DRUGCetuximab
Sponsors
Intergroupe Francophone de Cancerologie Thoracique
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Treatment Failure | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 1 month |
| Response Rate | 9 months |
| Overall survival | 6 months |
| Progression-Free Survival | 6 months |
Countries
France
Outcome results
None listed