Spots Global Cancer Trial Database for Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC
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Trial Identification
Brief Title: Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC
Official Title: Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer
Study ID: NCT02039336
Conditions
Study Description
Brief Summary: This is a phase I/II multi-center open-label proof of concept study, consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant (KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy the progression free survival of patients with KRASm NSCLC will be doubled.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Netherlands Cancer Institute, Amsterdam, , Netherlands
Erasmus Medical Center Cancer Institute, Rotterdam, , Netherlands
University Medical Center Utrecht, Utrecht, , Netherlands
Contact Details
Name: f opdam, MD, PhD
Affiliation: The Netherlands Cancer Institute
Role: STUDY_DIRECTOR
Name: FALM Eskens, PhD
Affiliation: Erasmus Medical Centre Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: MPJK Lolkema, PhD
Affiliation: UMC Utrecht
Role: PRINCIPAL_INVESTIGATOR
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