| General information |
| Database: | DB00840 |
| Objective: | There is a major unmet need for effective treatments in patients with squamous cell carcinoma of the lung. LUXLung 8 compared afatinib (an irreversible ErbB family blocker) with erlotinib (a reversible EGFR tyrosine kinase inhibitor), as secondline treatment for patients with advanced squamous cell carcinoma of the lung. |
| Authors: | Soria JC, et al |
| Title: | Afatinib versus erlotinib as secondline treatment of patients with advanced squamous cell carcinoma of the lung (LUXLung 8): an openlabel randomised controlledphase 3 trial. |
| Journal: | Lancet Oncol. |
| Year: | 2015 |
| PMID: | 26156651 |
| Trial Design |
| Clinical Trial Id: | NCT01523587 |
| Agent: | Afatinib erlotinib
|
| Target: | NA
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced squamouscell non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an openlabel randomised controlledphase III trial. |
| Key Patients Feature: | adults with stage IIIB or IV squamous cell carcinoma of the lung who had progressed after at least four cycles of platinumbasedchemotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Afatinib versus erlotinib |
| Treatment Info: | Participants were randomly assigned (1:1) to receive afatinib (40 mg per day) or erlotinib (150 mg per day) until disease progression. The randomisation was done centrally with an interactive voice or theybbased response system and stratified by ethnic origin (eastern Asian vs noneastern Asian). Clinicians and patients were not masked to treatment allocation. |
| Primary End Point: | progression free survival assessed by independent central review (intentiontotreat population). The key secondary endpoint was overall survival. |
| Secondary End Point: | NA |
| Patients Number: | 795 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 6% vs 3%; p=0.0551 |
| Disease Control Rate: | in the afatinib group than in the erloinib group: 51% vs 40%; p=0.0020). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | in the afatinib group than in the erloinib group: median 2.6 months [95% CI 2.02.9] vs 1.9 months [1.92.1]; HR 0.81 [95% CI 0.690.96], p=0.0103 |
| Median OS A vs. C: | in the afatinib group than in the erloinib group (median 7.9 months [95% CI 7.28.7] vs 6.8 months [5.97.8]; HR 0.81 [95% CI 0.690.95], p=0.0077), |
| Adverse Event(agent arm): | The most common adverse events were diarrhoea, rash or acne, fatigue, and stomatitis in the afatinib group and rash or acne, diarrhoea, fatigue, and pruritus in the erlotinib group. The incidences of treatmentrelated grade 3 diarrhoea and of grade 3 stomatitis were higher with afatinib and the incidence of grade 3 rash or acne was higher with erlotinib |
| Conclusions: | The significant improvements in progression free survival and overall survival with afatinib compared with erlotinib, along with a manageable safety profile and the convenience of oral administration suggest that afatinib could be an additional option for the treatment of patients with squamous cell carcinoma of the lung. |