| General information |
| Database: | DB00773 |
| Objective: | The Lung Cancer Cetuximab Study is an openlabel, randomizedphase II pilot study of cisplatin and vinorelbine combined with the epidermal growth factor receptor (EGFR)targeted monoclonal antibody cetuximab versus cisplatin and vinorelbine alone, in patients with advanced EGFRexpressing, non small cell lung cancer (non small cell lung cancer). End points of the study are activity, safety and pharmacokinetics |
| Authors: | Rosell R, et al |
| Title: | Randomizedphase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as firstline therapy in EGFRexpressing advanced non small cell lung cancer. |
| Journal: | Ann Oncol. |
| Year: | 2008 |
| PMID: | 17947225 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer harboring epidermal growth factor receptor mutations |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cetuximab + cisplatin/vinorelbine |
| Study Type: | an openlabel, randomizedphase II pilot study |
| Key Patients Feature: | Chemotherapynaive patients with histologically or cytologically proven non small cell lung cancer, stage IV or stage IIIB with documented malignant pleural effusion, according to American Joint Committee on Cancer criteria, and immunohistochemical evidence of EGFR expression in the primary tumor and/or metastases, were enrolled. |
| Biomarker: | EGFRexpressing |
| Biomark Analysis: | NA |
| Control Group Info: | cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone |
| Treatment Info: | Following randomization, for a maximum of eight cycles, patients received threeweekly cycles of cisplatin (80 mg/m(2), day 1) and vinorelbine (25 mg/m(2) on days 1 and 8) alone or following cetuximab treatment (initial dose 400 mg/m(2), followed by 250 mg/m(2) weekly thereafter). |
| Primary End Point: | activity, safety and pharmacokinetics |
| Secondary End Point: | NA |
| Patients Number: | 86 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 28% in the cisplatin/vinorelbine arm (A) and 35% in the cetuximab plus cisplatin/vinorelbine arm (B). |
| Disease Control Rate: | NA |
| Median Time to Progression: | 3.4 months for cetuximab plus cisplatin/vinorelbine and 2.9 months for cisplatin/vinorelbine. |
| Median PFS A vs. C: | 4.6 months in arm A and 5.0 months in arm B, with PFS rates at 12 months of 0% and 15%, respectively. |
| Median OS A vs. C: | 7.3 months in arm A and 8.3 months in arm B. The 24month survival rates were 0% and 16%, respectively. |
| Adverse Event(agent arm): | The most common grade 3/4 hematological laboratory abnormalities included anemia and thrombocytopenia, which were seen with a similar frequency in both treatment arms; however, the addition of cetuximab was associated with an increase in the frequency of grade 4 neutropenia from 37% to 50% |
| Conclusions: | In the firstline treatment of advanced non small cell lung cancer, the combination of cetuximab plus cisplatinvinorelbine demonstrated an acceptable safety profile and the potential to improve activity over cisplatinvinorelbine alone. |