Combination Checkpoint Inhibitor Plus Erlotinib or Crizotinib for EGFR or ALK Mutated Stage IV Non-small Cell Lung Cancer

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT01998126
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    Ipilimumab 3 mg/kg x 4 (given with standard Erlotinib or Crizotinib based on mutation)
  • Erlotinib — DRUG
    Erlotinib 150 mg once daily or current tolerable dose (given with Ipilimumab)
  • Crizotinib — DRUG
    Crizotinib 250 mg twice daily or current tolerable dose (given with Ipilimumab)
  • Nivolumab — DRUG

Study Details

The goals of the overall study are to evaluate a recommended phase 2 dose and the short and long term toxicities of the combinations. This is a modified phase I trial of immune checkpoint inhibitors in combination with mutation - specific targeted therapy (crizotinib or erlotinib) at conventional doses stratified for presence of ALK (Anaplastic lymphoma kinase) or EGFR (epidermal growth factor receptor) mutation. The goals of the overall study are to evaluate a recommended phase 2 dose and the short and long term toxicities of the combinations.

Key Dates

Start date
Dec 2, 2013
Status verified
Mar 2018
Primary completion
May 9, 2017
Completion
Mar 29, 2018

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EGFR patients with ipilimumab
    ipilimumab and erlotinib in EGFR mutated patients
  • Experimental: ALK patients plus ipilimumab
    ipilimumab and crizotinib in ALK mutated patients
  • Experimental: EGFR patients with nivolumab
    nivolumab and erlotinib in EGFR mutated patients
  • Experimental: ALK patients plus nivolumab
    nivolumab and crizotinib in ALK mutated patients

Primary Outcome Measure

toxicity of ipilimumab and erlotinib in EGFR mutated patients [ Time Frame: 36 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Salt Lake City, UT

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Huntsman Cancer Institute· Salt Lake City, UT

Related Studies