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Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial

Phase 3
18 Years
Open (Enrolling)
Non Small Cell Lung Cancer (NSCLC)

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Trial Information

Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial

Erlotinib is registered in all patients affected with NSCLC in second and subsequent lines
with a small benefit on Overall Survival. Recent evidence suggest that patients with EGFR
mutations have a clear benefit when they are treated with EGFR tyrosine kinase inhibitors,
while the role of these drugs in wild-type EGFR patients, that are representing the large
majority (about 85-90%), is still unclear and no properly planned trials assessed before
this issue. Recently, indirect evidence on subgroup analyses on randomized trial suggest
that chemotherapy might be superior to erlotinib in wild-type EGFR patients.

Moreover, several authors do not recommend the use of EGFR determined with
immunohistochemistry (IHC) or FISH because they do not reproducibly predict outcome.

For these reasons the protocol was amended in May 2011 in a superiority trial of docetaxel
versus erlotinib, while the first version was aimed to assess the interaction with

Inclusion Criteria:

- Age 18 years or older

- Histological or cytological confirmation of NSCLC (may be from initial diagnosis of
NSCLC or subsequent biopsy). Only patients with available tissue samples may be
included in the study

- Absence of EGFR mutations of exons 19 or 21 (randomization)

- Locally advanced or metastatic NSCLC, not amenable to curative surgery or

- One prior platinum-based at adequate doses and taxane free regimen

- Measurable (uni-dimensional) disease by RECIST in a lesion not previously irradiated
or non-measurable disease

- ECOG-PS 0-2

- ANC greater than 1.5 x 109/L and platelets greater than 100 x 109/L

- Bilirubin level either normal or <1.5xULN

- AST (SGOT) and ALT (SGPT) <2.5xULN (≤5 x ULN if liver metastases are present)

- Serum creatinine <1.5xULN

- Effective contraception for both, male and female pts, if the risk of conception

- Recovery from all acute toxicities of prior therapies

- Provision of written informed consent to the analysis of biological markers

- Provision of written informed consent to enter the randomized part of the study

Exclusion Criteria:

- Prior therapy with an experimental agent whose primary mechanism of action is
inhibition of EGFR or its associated tyrosine kinase

- Prior chemotherapy with taxanes

- Newly diagnosed CNS metastases that have not yet been treated with surgery and/or
radiation. Pts with previously diagnosed and treated CNS metastases or spinal cord
compression may be considered if they have evidence of clinically SD (no steroid
therapy or steroid dose being tapered) for at least 28 daysLess than 14 days since
completion of prior radiotherapy or persistence of any radiotherapy related toxicity

- Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion
of the investigator, makes it inappropriate for the patient to be enrolled in the
study Known severe hypersensitivity to erlotinib or any of the excipients of this

- Known hypersensitivity to docetaxel, polysorbate 80 or other drugs formulated with
polysorbate 80, or any of the excipients of docetaxel

- Other co-existing malignancies or malignancies diagnosed within the last 5 years with
the exception of basal cell carcinoma or cervical cancer in situ

- Unable to swallow tablets

- Any evidence of clinically active interstitial lung disease (patients with chronic,
stable, radiographic changes who are asymptomatic or patients with uncomplicated
progressive lymphangitic carcinomatosis need not be excluded)

- As judged by the investigator, any evidence of severe or uncontrolled systemic
disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal

- As judged by the investigator, any inflammatory changes of the surface of the eye

- Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the patient to participate in the study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

12 months after the last patient is randomized

Safety Issue:


Principal Investigator

Alberto Scanni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fatebenefratelli and Ophthalmic Hospital


Italy: Ethics Committee

Study ID:




Start Date:

November 2007

Completion Date:

February 2013

Related Keywords:

  • Non Small Cell Lung Cancer (NSCLC)
  • Advanced NSCLC
  • EGFR
  • EGFR copy number
  • Kras mutations
  • EGRF mutations
  • Docetaxel
  • Erlotinib
  • Polymorphisms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms