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Tyrosine Kinase Inhibitor

Arm III (kinase inhibitor, targeted therapy, other treatment) for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By William Petty
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of progression on primary targeted treatment to death, assessed up to 3 years.
Awards & highlights

Summary

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.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Epidermal Growth Factor Receptor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of progression on primary targeted treatment to death, assessed up to 3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of progression on primary targeted treatment to death, assessed up to 3 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Secondary study objectives
Number of Mutations in Secondary Genes for Patients With PD-L1 Expression < 50%
Number of Participants With Adverse Events Measured Using Common Terminology Criteria for Adverse Events Version 4.0
Objective Response Rates for Patients Without High PD-L1 Expressing Cancers
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm III (kinase inhibitor, targeted therapy, other treatment)Experimental Treatment5 Interventions
Patients receive tyrosine kinase inhibitor therapy PO targeting initial oncogenic driver, a drug targeting the secondary mutation, or other treatment for about 3 weeks.
Group II: Arm II (kinase inhibitor, chemotherapy, immunotherapy)Experimental Treatment4 Interventions
Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks.
Group III: Arm I (nivolumab, pembrolizumab)Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Targeted Molecular Therapy
2017
Completed Early Phase 1
~10
Pembrolizumab
FDA approved
Chemotherapy
2003
Completed Phase 4
~3050
Immunotherapy
2016
Completed Phase 4
~1530

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,779 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,857 Previous Clinical Trials
41,006,685 Total Patients Enrolled
William PettyPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
71 Total Patients Enrolled
~2 spots leftby Sep 2025
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