Entry Detail
| General information | |
| Database: | DB00080 |
| Objective: | Sorafenib inhibits the Ras/Raf pathway, which is overactive in cancer patients with a KRAS mutation. To test the hypothesis that patients with non small cell lung cancer with KRAS mutation will benefit from treatment with sorafenib. |
| Authors: | Dingemans AM, et al |
| Title: | a phase II study of sorafenib in patients with platinumpretreated, advanced (Stage IIIb or IV) non small cell lung cancer with a KRAS mutation. |
| Journal: | Clin Cancer Res. |
| Year: | 2013 |
| PMID: | 23224737 |
| Trial Design | |
| Clinical Trial Id: | Dutch trial register.NL30000.029.09 |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced nonsquamous non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a multicenterphase II study of sorafenib monotherapy |
| Key Patients Feature: | patients with KRASmutated, stage IIIb or IV non small cell lung cancer that progressed after at least one platinumcontaining regimen |
| Biomarker: | harboring a KRAS mutation in codons 12, 13, or 61 |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Treatment consisted of sorafenib 400 mg twice daily until disease progression or unacceptable toxicity. |
| Primary End Point: | disease control rate (DCR) at 6 weeks. |
| Secondary End Point: | NA |
| Patients Number: | 57 |
| Trial Results | |
| DLT_MTD: | sorafenib 400 mg twice daily until disease progression or unacceptable toxicity |
| Objective Response Rate: | NA |
| Disease Control Rate: | 6week DCR:52.6% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2.3 |
| Median OS A vs. C: | 5.3 |
| Adverse Event(agent arm): | Sorafenibrelated grade III/IV toxicity was reported in 10 patients (17.5%); all but one patient experienced grade III skin toxicity (14.0%) or grade III gastrointestinal toxicity (8.8%). |
| Conclusions: | Treatment with sorafenib has relevant clinical activity in patients with non small cell lung cancer harboring KRAS mutations. Further randomized study with this agent is warranted as singleagent or combination therapy. |