| General information |
| Database: | DB01001 |
| Objective: | Necitumumab is a secondgeneration, recombinant, human immunoglobulin G1 EGFR antibody. In this study, they aimed to compare treatment with necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone in patients with previously untreated stage IV squamous non small cell lung cancer. |
| Authors: | Thatcher N, et al |
| Title: | vandetanib in patients with inoperable hepatocellular carcinoma: a phase II, randomized, doubleblind, placebocontrolled study. |
| Journal: | Lancet Oncol. |
| Year: | 2015 |
| PMID: | 26045340 |
| Trial Design |
| Clinical Trial Id: | NCT00981058 |
| Agent: | necitumumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced squamous non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Necitumumab + gemcitabine |
| Study Type: | an openlabel, randomised, controlledphase III trial |
| Key Patients Feature: | Patients aged 18 years or older with histologically or cytologically confirmed stage IV squamous non small cell lung cancer, with an Eastern Cooperative Oncology Group (ECOG) performance status of 02 and adequate organ function and who had not received previous chemotherapy for their disease were eligible for inclusion. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone |
| Treatment Info: | Enrolled patients were randomly assigned centrally 1:1 to a maximum of six 3week cycles of gemcitabine and cisplastin chemotherapy with or without necitumumab according to a block randomisation scheme (block size of four) by a telephonebased interactive voice response system or interactive theyb response system. Chemotherapy was gemcitabine 1250 mg/m(2) administered intravenously over 30 min on days 1 and 8 of a 3week cycle and cisplatin 75 mg/m(2) administered intravenously over 120 min on day 1 of a 3week cycle. Necitumumab 800 mg, administered intravenously over a minimum of 50 min on days 1 and 8, was continued after the end of chemotherapy until disease progression or intolerable toxic sideeffects occurred. |
| Primary End Point: | overall survival, analysed by intention to treat. |
| Secondary End Point: | NA |
| Patients Number: | 1093 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Necitumumab plus gemcitabine and cisplatin vs Gemcitabine and cisplatin: 31% vs 29% |
| Disease Control Rate: | Necitumumab plus gemcitabine and cisplatin vs Gemcitabine and cisplatin: 82% vs 77% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Necitumumab plus gemcitabine and cisplatin vs Gemcitabine and cisplatin: 5.7 (5.6-6.0) months vs 5.5 (4.8-5.6) months |
| Median OS A vs. C: | in the necitumumab plus gemcitabine and cisplatin group vs in the gemcitabine and cisplatin alone group: median 11.5 months [95% CI 10.412.6]) vs 9.9 months [8.911.1]; stratified hazard ratio 0.84 [95% CI 0.740.96; p=0.01] |
| Adverse Event(agent arm): | 388 (72%) of 538 patients in the necitumumab plus gemcitabine and cisplatin group and 333 (62%) of 541 in the gemcitabine and cisplatin group had one or more grade 3 or worse treatmentemergent adverse events |
| Conclusions: | Our findings show that the addition of necitumumab to gemcitabine and cisplatin chemotherapy improves overall survival in patients with advanced squamous non small cell lung cancer and represents a new firstline treatment option for this disease. |