Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)

Part of paid clinical trials in La Jolla, California.

Sponsor
Pfizer
Study ID
NCT02349633
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PF-06747775 — DRUG
  • Palbociclib — DRUG
  • Avelumab — DRUG

Study Details

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 Dates

First listed
Jan 29, 2015
Start date
May 14, 2015
Status verified
May 2021
Primary completion
May 28, 2020
Completion
May 28, 2020

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Cohort 1 will be initiated (current dose 200 mg)
  • Experimental: Cohort 2A
    Cohort 2A will evaluate PF-06747775 200 mg by mouth (PO) daily (QD) in combination with palbociclib continuous PO QD dosing in 21-day cycles. The starting dose (DL1) for palbociclib will be 100 mg PO daily. Dose finding will follow mTPI method with adjustments using DLT rate.
  • Experimental: Cohort 2B
    Cohort 2B will be initiated once the RP2D of the PF-06747775 and palbociclib combination is determined.
  • Experimental: Cohort 3
    Cohort 3 combination is PF-06747775 200 mg PO QD and avelumab 10 mg/kg IV Q2W in 28-day (4-week) cycles. Dose finding will follow the mTPI design. Once RP2D of PF-06747775 in combination with avelumab is determined, the Dose Expansion Phase will be opened.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A [ Time Frame: 21 days for Phase 1 dose-escalation cohorts and Japan LIC; 42 days for Phase 1b Cohort 2A; 28 days for Phase 1b Cohort 3 ]

Locations (7)

FacilityCityStateZIPSite coordinators
UC San Diego Medical Center - La JollaLa JollaCalifornia92037-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
UC San Diego Medical Center - HillcrestSan DiegoCalifornia92103-
Smilow Cancer Hospital at Yale-New HavenNew HavenConnecticut06510-
UPMC Cancer PavilionPittsburghPennsylvania15232-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in La Jolla, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
UC San Diego Medical Center - La Jolla· La Jolla, CAUC San Diego Moores Cancer Center· La Jolla, CAUC San Diego Medical Center - Hillcrest· San Diego, CASmilow Cancer Hospital at Yale-New Haven· New Haven, CTUPMC Cancer Pavilion· Pittsburgh, PAUPMC Hillman Cancer Center· Pittsburgh, PA

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