drugset / Trial / NCT02322281
TIGER-3: Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the PFS, with that of single-agent cytotoxic chemotherapy in patients with EGFR-mutated, advanced/metastatic NSCLC after failure of at least 1 previous EGFR-directed TKI and at least 1 line of platinum-containing doublet chemotherapy.
Timeline
- Start
- 2015-02
- Primary completion
- 2018-03-29
- Completion
- 2018-03-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | 35 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Rociletinib | Small molecule | 500 mg | Oral |
| Subject | Rociletinib | Small molecule | 625 mg | Oral |