drugset / Trial / NCT02450656
Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer
Phase 1/2
Unknown
320 enrolled
The Netherlands Cancer Institute
AstraZeneca · collabBoehringer Ingelheim · collab
RandomizedCrossoverOpen-labelTreatment
Summary
This is a multi-center open-label proof-of-concept study consisting of two parts: PART A - a phase I dose-finding study (3 + 3 classical design) evaluating the RP2D of afatinib in combination with selumetinib in KRASm NSCLC; and PART B - a randomized phase II study investigating the progression free survival and safety of selumetinib/afatinib combination therapy compared to standard of care chemotherapy in KRASm NSCLC.
Timeline
- Start
- 2015-06
- Primary completion
- 2019-05
- Completion
- 2019-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afatinib | Small molecule | — | — |
| Comparator | Docetaxel | Small molecule | — | — |
| Subject | Selumetinib | Small molecule | — | — |