drugset / Trial / NCT02079636
A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to evaluate the safety and tolerability of abemaciclib in combination with another anti-cancer drug in participants with NSCLC that is advanced or has spread to other parts of the body (stage IV). The study will also investigate how the body processes the combination treatment and how the study drug affects the body. The study will also collect disease-related symptoms and participant-reported pain related to NSCLC.
Timeline
- Start
- 2014-03-28
- Primary completion
- 2018-05-02
- Completion
- 2019-08-29
Publications
- Kim ES, Kelly K, Paz-Ares LG, Garrido P, Jalal S, Mahadevan D, Gutierrez M, Provencio M, Schaefer E, Shaheen M, Johnston EL, Turner PK, Kambhampati SRP, Beckmann R, Hossain A, John WJ, Goldman JW. Abemaciclib in Combination with Single-Agent Options in Patients with Stage IV Non-Small Cell Lung Cancer: A Phase Ib Study. Clin Cancer Res. 2018 Nov 15;24(22):5543-5551. doi: 10.1158/1078-0432.CCR-18-0651. Epub 2018 Aug 6.
- Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 100 mg | Oral |
| Subject | Abemaciclib | Small molecule | 150 mg | Oral |
| Subject | Abemaciclib | Small molecule | 200 mg | Oral |
| Subject | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Ramucirumab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Subject | Ramucirumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Samotolisib | Small molecule | 100 mg | Oral |
| Subject | Samotolisib | Small molecule | 150 mg | Oral |
| Subject | Samotolisib | Small molecule | 200 mg | Oral |