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Pilot Study to Identify the Mechanism of De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors (EGFR-TKIs) in NSCLC With EGFR Mutation.


N/A
20 Years
80 Years
Not Enrolling
Both
NSCLC

Thank you

Trial Information

Pilot Study to Identify the Mechanism of De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors (EGFR-TKIs) in NSCLC With EGFR Mutation.


Investigators will prospectively enroll patients who match the following criteria:
pathologically proven unresectable NSCLC, planning to treat with EGFR-TKI, patients with
activating EGFR mutations, and available tissue sample for DNA extraction.


Inclusion Criteria:



1. Pathologically proven unresectable NSCLC

2. 20 years of age or older

3. Planned treatment with Iressa®

4. Patients with activating EGFR mutation (del 19, L858R)

5. Available detailed smoking history

6. Available tissue samples (archival tissue) for mutational or molecular analysis
(representative paraffin block or unstained sections from tumor diagnostic specimen
are mandatory)

7. Available blood sample

8. At least one lesion that is measurable according to the RECIST 1.1 criteria by CT or
MRI

9. Written informed consent

Exclusion Criteria:

1. More than 3rd line treatment

2. Previously treated with other EGFR-TKI

3. Life expectancy of less than 12 weeks

4. Pregnant or lactating female

5. Any unresolved toxicity greater than CTC grade 2 (version 4.0) from previous anti
cancer treatment.

6. Unsuitable patient in this treatment as determined by doctor.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

hazard rates of PFS

Outcome Description:

The primary objective is to compare hazard rates of PFS in patients treated with Iressa between with and without any molecular aberrancy in EGFR-downstream genes/proteins.

Outcome Time Frame:

1year

Safety Issue:

No

Principal Investigator

Joo Hang Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Severance Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

ISSIRES0067

NCT ID:

NCT01697163

Start Date:

October 2012

Completion Date:

September 2014

Related Keywords:

  • NSCLC
  • De Novo Resistance
  • Iressa
  • EGFR mutation
  • lung cancer

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