TerminatedPhase 2NCT02949843
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedChemotherapy and Immunotherapy

Plus 5 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 28, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Wake Forest University Health Sciences
Interventions being studied
Drug: Chemotherapy; Biological: Immunotherapy; Other: Laboratory Biomarker Analysis; Biological: Nivolumab; Biological: Pembrolizumab; Drug: Targeted Molecular Therapy; Drug: Tyrosine Kinase Inhibitor
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Patients must have histologically or cytologically confirmed incurable non-small cell lung cancer that harbors an activating mutation in EGFR, MET, BRAF, V600E, RET, HER2, translocation in Alk, or translocation in ROS-1
  • Patients must be receiving treatment or planning to start treatment with a tyrosine kinase inhibitor targeting the activated gene
  • Patients may not be receiving the treatment targeting the activated gene as part of a clinical treatment trial other than the Precision Oncology Trial
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
  • Total bilirubin =\< 1.5 X institutional upper limit of normal
  • Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine transaminase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Reasons someone may not be able to joinExclusion criteria
  • Emergent need for palliative radiation
  • Patients may not be receiving any other investigational agents for the treatment of non-small cell lung cancer
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded; breastfeeding should be discontinued

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Comprehensive Cancer Center of Wake Forest UniversityWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 28, 2024. Always confirm current availability with the study team.

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