Know Cancer

forgot password

The Role of PET During Erlotinib Treatment to See the Responsiveness of Tumor Early in Patients With Non-small Cell Lung Cancer

18 Years
85 Years
Open (Enrolling)
Erlotinib, Lung Cancer

Thank you

Trial Information

The Role of PET During Erlotinib Treatment to See the Responsiveness of Tumor Early in Patients With Non-small Cell Lung Cancer

1. Primary objectives:

To see whether the % change in SUVmax of a tumor with FLT-PET or FDG-PET at 7 days
after initiating erlotinib treatment compared with baseline SUVmax (ΔSUVmax) would
predict the tumor's responsiveness. And the responsiveness will be decided with the CT
scan after 6 weeks of erlotinib treatment.

2. Secondary objectives:

To compare ΔSUVmax and the degree of tumor shrinkage in longest diameter during erlotinib

To see ΔSUVmax in the tumors with stable disease. To see the time to progression and overall
survival according to ΔSUVmax. To compare the result of FDG-PET and FLT-PET.

Inclusion Criteria:

- > 18 years of age

- Histologically documented non-small cell lung cancer with metastasis (Stage IV) or
locally advanced (Stage IIIB) with malignant effusion.

- At least 1 measurable lesion as defined by RECIST. All target lesions must have a
unidirectional diameter of at least 1cm. Baseline measurements must be compared
within 4 weeks prior to enrollment.

- ECOG PS 0-2

- At least 3 weeks since the 1st line systemic therapy regimen prior to enrollment.
Patients must have recovered to NCI CTCAE v3.0 grade I from all toxicities. But 1st
line erlotinib treatment is also allowed.

- 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:

- Prior EGFR TKI treatment.

- 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.

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

- Pregnancy or breast feeding.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective


Korea : Korean Food and Drug Administration (KFDA)

Study ID:




Start Date:

June 2009

Completion Date:

December 2011

Related Keywords:

  • Erlotinib
  • Lung Cancer
  • Tarceva
  • Positron emission technology
  • FLT
  • FDG
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms