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Phase 4 Study of Response to EGFR-TKI and Correlation With C-met Expression and EGFR Gene Mutation in NSCLC Patients Treated With Erlotinib


N/A
19 Years
80 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Recurrent

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Trial Information

Phase 4 Study of Response to EGFR-TKI and Correlation With C-met Expression and EGFR Gene Mutation in NSCLC Patients Treated With Erlotinib


Inclusion Criteria:



- Informed consent

- 19~80 year old male or female

- Histologically proven advanced or metastatic NSCLC

- Failed to 1st line chemotherapy

- Tumor tissue for genetic analysis

- Evaluable target lesion by RECIST v1.1

- ECOG performance from 0 to 3

- Expected survival more than 12 weeks

Exclusion Criteria:

- Previous treatment of EGFR-tyrosine kinase inhibitors

- Severe hypersensitivity to erlotinib

- Residual toxicities (above grade 2) after previous chemotherapy

- Total bilirubin more than 1.5x of upper normal limit Liver function tests more than
2.5x of upper normal limits

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The rates of C-met expression/amplification and EGFR gene mutations

Outcome Description:

To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib : C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR

Outcome Time Frame:

Average of 1 year

Safety Issue:

No

Principal Investigator

Young-Chul Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chonnam National University Hospital

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

MENTOR_2011

NCT ID:

NCT01523340

Start Date:

December 2011

Completion Date:

December 2015

Related Keywords:

  • Non-small Cell Lung Cancer Metastatic
  • Non-small Cell Lung Cancer Recurrent
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary

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