iressa re-challenge in advanced nsclc egfr m+ patients who responded to gefitinib used as 1st line or previous treatment

Conditions: Lung Cancer

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

a phase ii open label, multicentre, single arm study to characterise the efficacy, safety and tolerability of gefitinib 250 mg (iressa�) as 3rd line treatment re-challenge in patients, who have epidermal growth factor receptor (egfr) mutation positive locally advanced or metastatic non-small cell lung cancer (nsclc) and who responded to gefitinib in 1st line and progressed after 2nd line chemotherapy

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