Iressa Re-Challenge in Advanced NSCLC EGFR M+ Patients Who Responded to Gefitinib USed as 1st Line or Previous Treatment
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Gefitinib 250mg
Intervention description: Gefitinib 250mg once daily
Intervention MeSH terms: Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      the primary objective is to characterise the impact of gefitinib on the Response Evaluation
      Criteria in Solid Tumours (RECIST) based assessments; objective response rate (ORR ;
      confirmed complete response(CR) or partial response (PR)) and disease control rate (DCR;
      confirmed complete response(CR) or partial response (PR) or stable disease (SD)) in patients
      with EGFR M+ NSCLC
    

Eligibility criteria:

        Inclusion Criteria at screening (Visit 1) and at Start of Study Treatment (Visit 2):

          -  Provision of informed consent prior to any study specific procedures.

          -  Histologically or cytologically confirmed NSCLC with an activating sensitising EGFR TK
             mutation as it was determined before starting the first gefitinib treatment by using a
             well-validated and robust methodology: adenocarcinoma, including Bronchoalveolar
             Carcinoma (BAC), squamous cell carcinoma, large cell carcinoma, adenosquamous
             carcinoma or undifferentiated carcinoma or not-otherwise specified NSCLC.

               -  Female or male patients aged 18 years or over with Locally advanced or metastatic
                  stage IIIB/IV disease, not suitable for therapy of curative intent or stage IV
                  (metastatic) disease, eligible for gefitinib re-challenge treatment for NSCLC who
                  have already received gefitinib with a documented complete (CR) or partial
                  response (PR) or stable disease (SD) >12 weeks as the best response to their 1st
                  gefitinib treatment and progressing during or after a subsequent anti-cancer
                  therapy (excluding EGFR-TKIs) treatment, including but not limited to doublet
                  platinum based chemotherapy or docetaxel monotherapy or pemetrexed monotherapy.

               -  Measurable disease defined as 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 spiral CT or MRI and
                  which is suitable for accurate repeated measurements.

               -  WHO / ECOG / Zubrod performance status 0-2.

        Exclusion Criteria:

          -  Known severe hypersensitivity to gefitinib or any of the excipients of the product

          -  Prior EGFR TKIs except gefitinib followed by subsequent anti-cancer treatment
             (including chemotherapy and excluding EGFR-TKIs).

        Previous adjuvant chemotherapy is allowed. Prior surgery or radiotherapy must be completed
        more than 6 months before start of study treatment. Palliative radiotherapy must be
        completed at least 4 weeks before start of study treatment with no persistent radiation
        toxicity.

          -  Progression disease or stable disease (SD) <12 weeks as best response to the 1st line
             treatment with gefitinib

          -  Not progressing during or after the last anti-cancer treatment.

          -  Considered to require radiotherapy to the lung at the time of study entry or in the
             near future

          -  Past medical history of interstitial lung disease, drug-induced interstitial disease,
             radiation pneumonitis which required steroid treatment or any evidence of clinically
             active interstitial lung disease

          -  Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline

          -  Insufficient lung function as determined by either clinical examination or an arterial
             oxygen tension (PaO2) of < 70 Torr

          -  Known or suspected brain metastases or spinal cord compression, unless treated with
             surgery and/or radiation and stable without steroid treatment for at least 4 weeks
             prior to the first dose of study medication

          -  Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer
             therapy

          -  Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine,
             rifampicin, barbiturates, or St John's Wort

          -  Pregnancy or breast-feeding

          -  As judged by the investigator, any evidence of severe or uncontrolled systemic disease
             (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

          -  Evidence of any other significant clinical disorder or laboratory finding that makes
             it undesirable for the patient to participate in the study

          -  Other co-existing malignancies or malignancies diagnosed within the last 5 years with
             the exception of basal cell carcinoma or cervical cancer in situ

          -  Life expectancy of less than 12 weeks