Clinical trialPhase 1 / Phase 2Completed
Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC
Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer
- Outcome
- Finished, no results posted
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 2 April 2014
- Expected end
- 7 August 2018
- Enrollment
- 35 participants
- Sites
- 3
- Primary outcomes
- Incidence rate of dose-limiting toxicities; Progression free survival
- Sponsor
- Other
- Results posted
- No
- Last update
- 8 July 2025
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Brief summary public domain (ClinicalTrials.gov)
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.