Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase 1/2 Study of the Safety and Efficacy of Rociletinib When Administered in Combination With Trametinib in Patients With Activating EGFR Mutation-positive Advanced or Metastatic Non-small Lung Cancer (NSCLC)
The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib when administered in combination with trametinib.
This is a Phase 1/2, open-label, non randomized, multicenter study evaluating the safety and
efficacy of rociletinib administered in combination with trametinib.
This study will be conducted in 2 phases:
Phase 1: This will be the dose escalation phase of the study. Phase 1 will determine the MAD
or MTD and RP2D of the combination of rociletinib and trametinib, and evaluate its safety and
tolerability and PK profile in EGFRm NSCLC patients who have failed at least one prior EGFR
TKI.
Phase 2: This will be the dose expansion phase. Phase 2 will evaluate the preliminary
efficacy and pharmacodynamics of the combination of rociletinib and trametinib at the RP2D in
two subsets of EGFRm NSCLC patients.
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