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A Prospective Registry for Patients With Acquired Resistance to Small Molecule Kinase Inhibitors in Non-Small-Cell Lung Cancer


N/A
N/A
N/A
Open (Enrolling)
Both
Unresectable or Metastatic Non-small Cell Lung Cancer (NSCLC)

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Trial Information

A Prospective Registry for Patients With Acquired Resistance to Small Molecule Kinase Inhibitors in Non-Small-Cell Lung Cancer


The goal of this protocol is to determine mechanisms of resistance to epidermal growth
factor (EGFR) tyrosine kinase inhibitors (EGFR-TKI) in non-small cell lung cancer (NSCLC). A
number of trials have shown small molecule kinase inhibitors to be active agents in the
treatment of NSCLC [1]. Clinically these drugs have been noted to produce dramatic but
infrequent responses. Mutations in the epidermal growth factor receptor have been shown to
correlate with sensitivity to gefitinib and erlotinib[2,3]. However, we know that most
patients who have initial responses to EGFR-TKI eventually progress. The mechanism of
acquired clinical resistance to these inhibitors in patients incompletely understood.

This is a protocol to study clinical characteristics and biopsy tissue of patients with
non-small cell lung cancer who have had previous clinical response to small molecule kinase
inhibitors and subsequently experience progression of disease. The tissues and other
specimens will be used to carry out laboratory studies to explore the molecular basis of
sensitivity and resistance to small molecule kinase inhibitors.


Inclusion Criteria:



Patients diagnosed with unresectable or metastatic non-small cell lung cancer (NSCLC) and
who fulfill the following eligibility criteria will be considered eligible for this study.

- Patient must have previously received treatment with small molecule kinase inhibitors
targeting at least, in part, EGFR patients may have received other treatments since
treatment with small molecule kinase inhibitors including radiation or chemotherapy)

- Development of disease progression while actively receiving tyrosine kinase inhibitor

- Signed informed consent

Exclusion Criteria:

- None

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To compare EGFR gene sequence in patients upon relapse with EGFR gene sequence prior to treatment with small molecule kinase inhibitors.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Gregory J Riely, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

04-103

NCT ID:

NCT00579683

Start Date:

August 2004

Completion Date:

August 2013

Related Keywords:

  • Unresectable or Metastatic Non-small Cell Lung Cancer (NSCLC)
  • non-small cell lung cancer
  • NSCLC
  • metastatic disease
  • resistent disease
  • RNA analysis
  • 04-103
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memoral Sloan Kettering Cancer CenterBasking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memoral Sloan Kettering Cancer Center at PhelpsSleepy Hollow, New York  10591
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York