Non small cell lung cancer
Conditions
Interventions
Trade Name: Gefitinib
Product Name: Iressa
Product Code: 13166
Pharmaceutical Form: Tablet
INN or Proposed INN: Iressa
CAS Number: 184475-35-2
Other descriptive name: GEFITINIB
Concentration unit: mg
Sponsors
Nederlandse Vereniging van Artsen voor Longziekten en Tuberculose NVALT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 2. 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. 3. 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. 4. WHO / ECOG / Zubrod performance status 0-2. 5. Possibility of obtaining tumour material before the start of the study treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 92 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known severe hypersensitivity to gefitinib or any of the excipients of the product 2. 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. Previous adjuvant chemotherapy is allowed. 3. Progressive disease or stable disease (SD) <12 weeks as best response to the 1st line treatment with an EGFR-TKI 4. Consideration to require radiotherapy to the lung at the time of study entry or in the near future 5. 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 6. Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation. 7. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy 8. Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort 9. Pregnancy or breast-feeding 10. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) 11. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study 12. Other co-existing malignancies or malignancies diagnosed within the last 2 years with the exception of basal cell carcinoma or cervical cancer in situ 13. Life expectancy of less than 12 weeks 14. Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment 15. Involvement in the planning and/or conduct of the study (applies to both NVALT staff or staff at the study site) 16. Previous enrolment or treatment in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Disease control rate;Secondary Objective: The secondary objectives of the study are: objective response rate (ORR) according to RECIST, progression free survival (PFS) according to RECIST, overall Survival (OS), EGFR Mutational status of tumour tissue both activating and resistance EGFR mutations analysis and the association between the Veristrat assay (Biodesix) and both PFS and OS will be assessed.;Primary end point(s): Disease control rate;Timepoint(s) of evaluation of this end point: Disease control rate - end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives of the study are: objective response rate (ORR) according to RECIST, progression free survival (PFS) according to RECIST, overall Survival (OS), EGFR Mutational status of tumour tissue both activating and resistance EGFR mutations analysis and the association between the Veristrat assay (Biodesix) and both PFS and OS will be assessed.;Timepoint(s) of evaluation of this end point: Objective response rate (ORR) according to RECIST - end of study Progression free survival (PFS) according to RECIST - end of study Overall Survival (OS) - end of study EGFR Mutational status of tumour tissue both activating and resistance EGFR mutations analysis - at baseline and at progression Association between the Veristrat assay (Biodesix) and both PFS and OS will be assessed - End of study | — |
Countries
Netherlands
Contacts
Public ContactPrincipal investigator
NVALT
Outcome results
None listed