Non-small cell lung cancer (NSCLC) at the stage advanced / metastatic with receptor sensitizing mutation for growth factor epidermal (EGFR) MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: IRESSA - 250 MG COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER(PVC/AL) NON PERFORATO 30 COMPRESSE
Product Name: GEFITINIB
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN:
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, minimum age 18 years. 2. ECOG performance status of 0 to 2. 3. Adequate haematological function: haemoglobin > 9 g/dL, neutrophils count >1.5 × 109/L, platelet count > 100 × 109/L. 4. Adequate coagulation: INR = 1.5. 5. Adequate liver function: total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 27
Exclusion criteria
Exclusion criteria: 1. Active second malignancy; i.e., patient known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment. 2. Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enrol in the trial provided all chemotherapy was completed > 6 months prior and/or bone marrow transplant > 2 years prior to first day of study treatment. 3. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. 4. Patients with moderate to severe hepatic impairment (Child Pug B or C) due to cirrhosis. 5. Patients with active keratitis and severe ocular diseases. 6. Spinal cord compression, symptomatic and unstable brain metastases, requiring steroids over the last 4 weeks prior to enrollment in this study. 7. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of gefitinib. 5. Non-study related surgical procedures less than or equal to 7 days prior to administration of study drug. In all cases, the patient must be sufficiently recovered and stable before treatment administration. 6. Females who are pregnant or breastfeeding. 7. Refusal to use adequate contraception for fertile patients (females and males) for 24 weeks after the last dose of gefitinib. 8. Patients with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient’s capacity to participate in the study. 9. Any other reason the investigator considers the patient should not participate in the study. Prior, recent or concurrent treatment 1. Prior treatment with cytotoxic chemotherapy for advanced NSCLC; neoadjuvant/adjuvant chemotherapy is permitted if at least 6 months has elapsed between the end of chemotherapy and enrollment 2. Patients who received previous treatment for lung cancer with drugs targeting EGFR. 3. Patients who received treatment with an investigational drug agent during the 3 weeks before enrolment in the study. 4. Treatment with prohibited medications less than or equal to14 days prior to first day of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy in term of PFS rate at 12 months of gefitinib in the treatment of patients with advanced EGFR mutant adenocarcinoma, according to the TP53 mutational status.;Secondary Objective: ¿ To evaluate secondary measures of clinical efficacy including overall survival (OS), overall response rate (ORR), time to treatment failure (TTF), disease control rate (DCR) and duration of response (DoR), adverse events (AE) according to the TP53 mutational status. ¿ To evaluate the efficacy data according to the proportion of mutated alleles for EGFR and the presence of coexisting genetic alterations. ¿ To monitor and quantify EGFR mutations (including T790M) in plasma and urine during treatment. ¿ To determine the feasibility of re-biopsies at the time of progression for biomarkers analysis related to mechanisms of resistance and decision-making for second-line treatment. ¿ To assess the feasibility and the applicability of innovative technologies (NGS) in the diagnosis and monitoring of lung cancer patients. ¿ To compare the results obtained in tissue, in blood and urine with NGS. ;Primary end point(s): Progression-free survival (PFS) rate at 12 months;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS); Objective response rate (ORR) ; Time to treatment failure (TTF); Duration of response (DoR); Adverse events (AEs) graded according to CTCAE V4.0; Disease control rate (DCR);Timepoint(s) of evaluation of this end point: From first dose to end of study or date of death from any cause, whichever comes first, assessed every 8 weeks; At baseline and every 8 weeks from time of first dose, participants will be followed by PET-CT, CT or MRI scans for RECIST 1.1 until date of progression; From first dose to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death, assessed every 8 weeks; At baseline and every 8 weeks from time of first dose, participants will be followed by PET-CT, CT or MRI scans for RECIST 1.1 until date of progression; AEs will be collected from baseline until 28 days after the last dose; At baseline and every 8 weeks from time of first dose, participants will be followed by PET-CT, CT or MRI scans for RECIST 1.1 until date of pr | — |
Countries
Italy
Contacts
Public ContactUnità Ricerca Clinica
Azienda Ospedaliera Integrata Universitaria Verona
Outcome results
None listed