Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)
Stopped early · Phase 1/Phase 2
Conditions studied: Non-Small Cell Lung Cancer
In brief
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).
Key facts
- Study ID
- NCT02349633
- Run by
- Pfizer
- People needed
- 65
- Starts
- 2015-05-14
- Expected to finish
- 2020-05-28
- Last updated by the study team
- 2021-06-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UC San Diego Medical Center - La Jolla — La Jolla, California, United States
- UC San Diego Moores Cancer Center — La Jolla, California, United States
- UC San Diego Medical Center - Hillcrest — San Diego, California, United States
- Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut, United States
- UPMC Cancer Pavilion — Pittsburgh, Pennsylvania, United States
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
- Seattle Cancer Care Alliance — Seattle, Washington, United States
- Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
- Prince Charles Hospital, Cancer Care Services — Chermside, Queensland, Australia
- National Hospital Organization Shikoku Cancer Center — Matsuyama, Ehime, Japan
- The Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan
- Seoul National University Hospital / Department of Internal Medicine — Seoul, South Korea
- Severance Hospital, Yonsei University Health System — Seoul, South Korea
- Asan Medical Center — Seoul, South Korea
Full record on ClinicalTrials.gov
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