Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)
Status:
Terminated
Trial end date:
2020-05-28
Target enrollment:
Participant gender:
Summary
This is a Phase 1/2 study of PF-06747775 as a single agent and in combination with other
cancer treatments in patients with advanced EGFRm NSCLC. The overall clinical study consists
of a Phase 1 single agent dose-escalation and expansion part to determine the RP2D of
PF-06747775 single agent in patients with previously-treated EGFRm NSCLC followed by
sequential evaluations of PF-06747775 at the RP2D in 3 different clinical scenarios as
detailed below:
- Cohort 1: Phase 2 evaluation of PF-06747775 as a single agent in previously untreated
patients with advanced EGFRm NSCLC,
- Cohort 2: Phase 1b single arm evaluation of PF-06747775 in combination with palbociclib
(Cohort 2A) followed by Phase 2 randomized evaluation of PF 06747775 in combination with
palbociclib vs PF-06747775 single agent (Cohort 2B) in previously-treated patients with
EGFRm NSCLC with a secondary T790M mutation (del 19 and T790M or L858R and T790M), and
- Cohort 3: Phase 1b evaluation of PF-06747775 in combination with avelumab in
previously-treated patients with EGFRm NSCLC with a secondary T790M mutation (del 19 and
T790M or L858R and T790M).