Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT02949843
Phase
PHASE2
Status
Terminated

Conditions

  • EGFR Activating Mutation
  • Recurrent Non-Small Cell Lung Carcinoma
  • Stage IV Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Chemotherapy — DRUG
    Receive other treatment
  • Immunotherapy — BIOLOGICAL
    Receive other treatment
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Targeted Molecular Therapy — DRUG
    Receive drug targeting secondary mutation
  • Tyrosine Kinase Inhibitor — DRUG
    Given PO

Study Details

This phase II trial studies how well targeted therapy works in treating patients with incurable non-small cell lung cancer with a genetic mutation. Giving drugs that target other genetic mutations or other specific proteins may work better when a patient has cancer caused by a driver mutation and the treatment that targets that mutation stops working.

Key Dates

Start date
Mar 10, 2017
Status verified
Jun 2024
Primary completion
Jan 8, 2018
Completion
Jan 12, 2021

Study Design

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

Arms

  • Experimental: Arm I (nivolumab, pembrolizumab)
    Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (kinase inhibitor, chemotherapy, immunotherapy)
    Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks.
  • Experimental: Arm III (kinase inhibitor, targeted therapy, other treatment)
    Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks.

Primary Outcome Measure

Objective Response Rate in Patients With High PD-L1 Expressing Cancers After Failure of Targeted Therapy Defined as Complete or Partial Response According to the Investigator's Assessment [ Time Frame: Up to 1 year after failure of targeted therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
Comprehensive Cancer Center of Wake Forest UniversityWinston-SalemNorth Carolina27157-

Find similar trials in Winston-Salem, NC

By research site
Comprehensive Cancer Center of Wake Forest University· Winston-Salem, NC

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