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De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors

NCT ID: NCT01697163

Last Updated: 2012-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-09-30

Brief Summary

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This study is based on the following hypothesis "De novo resistance to EGFR-TKI in EGFR mutation positive patients is related with mutations in EGFR downstream genes".

Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification, and protein over expression as predictive markers of treatment outcomes, investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression. Investigators will attempt to identify biomarkers that are able to predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.

Detailed Description

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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.

Conditions

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NSCLC

Keywords

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De Novo Resistance Iressa EGFR mutation lung cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Iressa

Lung cancer patients with EGFR mutation

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joo Hang Kim

Severance Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joo Hang Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Central Contacts

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Joo Hang Kim, MD, PhD

Role: CONTACT

Phone: 82-2-2228-8131

Email: [email protected]

References

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Lim SM, Kim HR, Cho EK, Min YJ, Ahn JS, Ahn MJ, Park K, Cho BC, Lee JH, Jeong HC, Kim EK, Kim JH. Targeted sequencing identifies genetic alterations that confer primary resistance to EGFR tyrosine kinase inhibitor (Korean Lung Cancer Consortium). Oncotarget. 2016 Jun 14;7(24):36311-36320. doi: 10.18632/oncotarget.8904.

Reference Type DERIVED
PMID: 27121209 (View on PubMed)

Other Identifiers

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ISSIRES0067

Identifier Type: -

Identifier Source: org_study_id