Iressa Re-challenge in Advanced NSCLC EGFR-mutated Patients (IRENE)

This is an interventional treatment trial for Lung Cancer focused on measuring NSCLC, EGFR, TKI, Re-challenge, Lung Cancer, Resistance Read More

Inclusion Criteria:

• Histologically or cytologically confirmed NSCLC with an activating sensitising EGFR TK mutation as determined before starting the first EGFR-TKI treatment by using a well-validated and robust methodology
• 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 an EGFR-TKI with a documented complete (CR) or partial response (PR) or stable disease (SD) >12 weeks as the best response to their 1st EGFR-TKI treatment and who have received any subsequent anti-cancer therapy (excluding EGFR-TKIs) treatment, including but not limited to doublet platinum based chemotherapy or docetaxel monotherapy or pemetrexed monotherapy, on which they progressed.
• 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.
• Possibility of obtaining tumour material before the start of the study treatment.

Exclusion Criteria:

• Known severe hypersensitivity to gefitinib or any of the excipients of the product treatment with no persistent radiation toxicity. Previous adjuvant chemotherapy is allowed.
• Progressive disease or stable disease (SD) <12 weeks as best response to the 1st line treatment with an EGFR-TKI
• Consideration 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
• Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation.
• 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 2 years with the exception of basal cell carcinoma or cervical cancer in situ
• Life expectancy of less than 12 weeks
• Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
• Involvement in the planning and/or conduct of the study (applies to both NVALT staff or staff at the study site)
• Previous enrolment or treatment in the present study.