| General information |
| Database: | DB01005 |
| Objective: | Figitumumab (CP751, 871), a fully human immunoglobulin G2 monoclonal antibody, inhibits the insulinlike growth factor 1 receptor (IGF1R). Our multicenter, randomized, phase III study compared figitumumab plus chemotherapy with chemotherapy alone as firstline treatment in patients with advanced non small cell lung cancer (non small cell lung cancer). |
| Authors: | Langer CJ, et al |
| Title: | Randomized, phase III trial of firstline figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone in patients with advanced non small cell lung cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2014 |
| PMID: | 24888810 |
| Trial Design |
| Clinical Trial Id: | NCT00596830 |
| Agent: | figitumumab
|
| Target: | Insulinlike growth factor I receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | figitumumab + paclitaxel + carboplatin |
| Study Type: | Randomized, phase III trial |
| Key Patients Feature: | Patients with stage IIIB/IV or recurrent non small cell lung cancer disease with nonadenocarcinoma histology |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone |
| Treatment Info: | pts received openlabel figitumumab (20 mg/kg) plus paclitaxel (200 mg/m(2)) and carboplatin (area under the concentrationtime curve, 6 mg . min/mL) or paclitaxel and carboplatin alone once every 3 weeks for up to six cycles. |
| Primary End Point: | overall survival (OS). |
| Secondary End Point: | NA |
| Patients Number: | 681 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 33% and 35% for figitumumab plus chemotherapy and for chemotherapy alone |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.7 months (95% CI, 4.2 to 5.4) and 4.6 months (95% CI, 4.2 to 5.4), respectively (HR, 1.10; P = .27) |
| Median OS A vs. C: | 8.6 months for figitumumab plus chemotherapy and 9.8 months for chemotherapy alone (hazard ratio [HR], 1.18; 95% CI, 0.99 to 1.40; P = .06) |
| Adverse Event(agent arm): | Anygrade AEs that occurred more frequently in the figitumumab arm included hyperglycemia, diarrhea, decreased appetite, vomiting, and decreased weight. Grade 3/4 AEs that occurred more frequently in the figitumumab arm included hyperglycemia, decreased appetite, dehydration, diarrhea, fatigue, and nausea. |
| Conclusions: | Adding figitumumab to standard chemotherapy failed to increase OS in patients with advanced nonadenocarcinoma non small cell lung cancer. Further clinical development of figitumumab is not being pursued. |