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First Line Gefitinib Treatment for Advanced Non-small Cell Lung Cancer (NSCLC) by the FDG-PET Metabolic Response

Phase 2
19 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

First Line Gefitinib Treatment for Advanced Non-small Cell Lung Cancer (NSCLC) by the FDG-PET Metabolic Response

Gefitinib has anti-tumor activity as a result of EGFR tyrosine kinase inhibition, reducing
multiple downstream signaling processes that activate cell proliferation and other cell
responses, including cell migration angiogenesis, and reduced apoptosis. Recently, it has
been approved for the first line treatment of advanced NSCLC that harbors EGFR mutation. In
IPASS trial, tumors with EGFR mutation produced 71.2% of clinical response to first line
gefitinib while tumors with wild type EGFR showed only 1.1% of response. Therefore, patient
selection is critical for the clinical use of EGFR tyrosine kinase inhibitors as first line

When considering 1st line gefitinib treatment for NSCLC, we need EGFR mutational status of
the tumor. But most patients do not give us such information at the time of diagnosis,
because it requires tumor tissue and some time period for EGFR examination. So, we need
other strategies such as using PET scan for early prediction of response to gefitinib.

Glucose metabolic activity closely reflects responses to gefitinib therapy. In preclinical
study with gefitinib sensitive cell lines, there was a dramatic decrease in FDG uptake as
early as 2 hours after treatment. And these metabolic alterations preceded changes in cell
cycle distribution, thymidine uptake and apoptosis. In contrast, gefitinib resistant cells
exhibited no measurable changes in FDG uptake, either in cell culture or in vivo.

The strategy using FDG-PET may guide us to perform 1st line geftinib. Recently investigators
reported that FLT-PET or FDG-PET could predict response to EGFR tyrosine kinase (TKI) early
after 1 week of treatment. And % decrease more than 20% of maximum SUV of main lesion after
1 week of EGFR TKI treatment could predict response to that drug. More than 20% decrease of
SUV is a significant change during reproducibility test and also considered as a criteria
for response prediction of paclitaxel/cisplatin chemotherapy.

So, investigators develop a protocol of 1st line gefitinib treatment for NSCLC according to
FDG-PET response. And if the patient showed less than 20% decrease of peak SUV,
investigators will stop gefitinib and treat him or her with the regimen of

Inclusion Criteria

Inclusion criteria

- More than 18 years of age

- Advanced or metastatic adenocarcinoma of the lung. Non-smoking or light smoking
patients (less than 10 PY smoking and more than 10 years of ex-smoking period) are
preferred to enrich the patients with clinical response to gefitinib.

- Chemonaive patients.

- At least one lesion, not previously irradiated, that can be accurately measured at
baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short
axis ≥ 15 mm) with computed tomography (CT) or and which is suitable for accurate
repeated measurements.

- ECOG PS 0-2

- Patients with tissue for the detection of EGFR mutation

- At least 1 week since the last radiotherapy. Patients must have recovered from all
acute toxicities from radiotherapy.

- Patients must have adequate hematologic, renal and liver function as defined by Hb >
9g/dL, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dL, and AST
(SGOT) and/or ALT (SGPT) < 5 x UNL (upper normal limit).

- Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests and other study procedures.

- Written and voluntary informed consent understood, signed and dated.

Exclusion criteria

- Symptomatic brain metastasis. Brain metastases stable < 2 weeks before dosing or
requiring concurrent steroid treatment or with clinical symptoms.

- Major surgery within 3 weeks prior to study enrollment.

- Previous (less than 3 years ago) or current malignancies at sites other than
curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma
of the skin.

- Past medical history of interstitial lung diseas, drug induced interstitial disease,
radiation pneumonitis which required steroid treatment or any active interstitial
lung disease.

- Pre-existing idiopathic pulmonary fibrosis on CT scans on baseline.

- Insufficient lung function as determined by either clinical examination or an
arterial oxygen tension (PaO2) < 70mmHg.

- Uncontrolled diabetes mellitus and FBS > 150mg/dL.

- Severe medical illness or active infection that would impair the ability to receive

- Pregnancy or breast feeding.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response rate

Outcome Description:

The primary objective is to see the response rate of gefitinib in the patients who showed % decrease of peak SUV of main lesion 20% or more and continuously treated with gefitinib.

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Sang-We Kim, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

AMC 2011-0858



Start Date:

April 2012

Completion Date:

November 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small cell lung cancer
  • Gefitinib
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms