Overview

Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer

Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
The Netherlands Cancer Institute
Collaborators:
AstraZeneca
Boehringer Ingelheim
Treatments:
Afatinib
Capecitabine
Docetaxel
Irinotecan