Entry Detail
| General information | |
| Database: | DB00852 |
| Objective: | Sorafenib inhibits the Ras/Raf pathway, which is overactive in cancer patients with a KRAS mutation. they hypothesized that patients with non small cell lung cancer (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: | NCT00933777 |
| 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 (Stage IIIb or IV) non small cell lung cancer with a KRAS mutation |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | platinumpretreated+sorafenib |
| Study Type: | a phase II study |
| Key Patients Feature: | patients with KRASmutated, stage IIIb or IV non small cell lung cancer that progressed after at least one platinumcontaining regimen |
| Biomarker: | KRAS mutation |
| Biomark Analysis: | Treatment with sorafenib has relevant clinical activity in patients with non small cell lung cancer harboring KRAS mutations. |
| Control Group Info: | single arm |
| Treatment Info: | Treatment consisted of sorafenib 400 mg twice daily until disease progression or unacceptable toxicity. |
| Primary End Point: | Primary endpoint was disease control rate (DCR) at 6 weeks. |
| Secondary End Point: | NA |
| Patients Number: | 59 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 10.50% |
| Disease Control Rate: | 52.60% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2.3 months [95% confidence interval (CI), 1.6-3.0 months] |
| Median OS A vs. C: | 5.3 months (95% CI, 3.6-7.0 months) |
| Adverse Event(agent arm): | The most common adverse events reported were fatigue (6.4%), hand-foot reaction (5.7%), dyspnea (5.6%), anorexia (3.7%) diarrhea (3.6%), and cough (3.6%). Ten patients developed a grade III-IV (probable) sorafenibrelated adverse event |
| 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. |