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Brief Title: Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer
Official Title: Phase I/II Study With the Combination of Afatinib and Selumetinib in Advanced KRAS Mutant Positive and PIK3CA Wildtype Non-small Cell Lung Cancer
Study ID: NCT02450656
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UMC St. Radboud Nijmegen, Nijmegen, Gelderland, Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, , Netherlands
Name: F Opdam, MD, PhD
Affiliation: NKI-AvL
Role: PRINCIPAL_INVESTIGATOR