Multicentric Randomized Phase III Study Comparing Gefitinib Versus Platinum-Based Chemotherapy In EGFR Fish Positive NSCLC Patients (Range)
- Patients with locally advanced or metastatic NSCLC, EGFR FISH positive, candidate for
a first-line platinum-based chemotherapy
- Histologically confirmed diagnosis of non-squamous NSCLC. Availability of tumor
tissue for EGFR FISH analysis is mandatory
- Stage IIIB (with effusion) or stage IV or disease relapsed after surgery or
radiotherapy and in any case not suitable for radiotherapy or surgery with curative
- EGFR FISH positive
- Presence of at least one measurable/evaluable not previously irradiated lesion
according to RECIST criteria. Previously irradiated lesion(s) are allowed only if
- ECOG performance Status 0-2
- Patient untreated with chemotherapy or EGFR targeting agents. Adjuvant chemotherapy
is allowed if disease relapsed after at least 12 months after therapy completion.
- Patient candidate to standard platinum-based chemotherapy
- Patient compliance to trial procedures
- Patients must be willing to complete the FACT-L questionnaire
- Age ≥ 18 years
- EGFR FISH negative tumor
- Squamous-cell carcinoma, presence of neuroendocrine features or small cell carcinoma
- Impossibility to ascertain EGFR FISH status
- Concomitant radiotherapy
- Less than 30 days since completion of prior wide field chest radiotherapy or
persistence of any radiotherapy related toxicity.
- Symptomatic brain metastases or newly diagnosed central nervous system (CNS)
metastases that have not yet been definitively treated with surgery and/or radiation.
Patients with previously diagnosed and treated CNS metastases or spinal cord
compression may be considered if they have evidence of clinically stable disease and
are not receiving steroid therapy.
- Known severe hypersensitivity to gefitinib or any of the excipients of this product
- Any evidence of clinically active interstitial lung disease (patients with chronic,
stable, radiographic changes who are asymptomatic need not be excluded)
- All disease sites previously included in radiotherapy fields. If all sites were
included in radiotherapy fields patient is eligible only if there is evidence of
progressive disease after completion of radiotherapy.
- Diagnosis of any other malignancy during the last 5 years, except for in situ
carcinoma of cervix uterine and squamous cell carcinoma of the skin
- Any previous chemotherapy or EGFR targeting agents
- Pregnancy or lactating. Women of childbearing potential must practice acceptable
methods of birth control to prevent pregnancy
- Males must be willing to practice acceptable methods of birth control whilst taking
study medication to prevent pregnancy of a partner.
- As judged by the investigator, any evidence of severe or uncontrolled systemic
disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal
- Concomitant use of phenytoin, carbamazepine, rifampicin, rifabutin, barbiturates or
St John's Wort (Hypercium).
- Serum bilirubin greater than 3 times the upper limit of reference range (ULRR
- Alanine amino transferase (ALT) or aspartate aminotransferase (AST) greater than 2.5
times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR
in the presence of liver metastases.
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of