Locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor or who have responded to EGFR TKI MedDRA version: 14.1 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB System Organ Class: 100000004864 MedDRA version: 14.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Tarceva
Product Name: erlotinib
Product Code: RO508231
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ERLOTINIB
CAS Number: 183321-74-6
Sponsors
Oulu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent obtained prior to any study specific screening procedures. 2. Histologically confirmed stage IIIB/IV NSCLC. 3. Investigator confirmed progression according RECIST 1.1 during EGFR TKI treatment within 28 days of the randomization 4. Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting > 6 months 5. Age >18 6. Performance status: WHO 0-2 7. Measurable disease according to RECIST 1.1 8. Patients must be able to comply with study treatments 9. Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study 10. Neutrophils =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Previous EGFR TKI treatment beyond RECIST 1.1 defined disease progression for more than 28 days 2. Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment 3. Patient has history of hypersensitivity or intolerance to erlotinib or gefitinib 4. Patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study 5. Patient with symptomatic central nervous system metastases 6. Patient has known active hepatitis B or C, or HIV infection 7. Pregnant or breastfeeding. 8. Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study efficacy and safety of Erlotinib treatment beyound diasease progression in combination with chemotherapy compared to chemotherapy alone in stage IIIB/IV non-small cell lung cancer patients with EGFR activating mutations or who have responded EGFR TKIs- ;Secondary Objective: Overall survival, Objective response rate, Rate of non-progression at 9 and 18wks, Safety of the treatment, Predictive biomarkers for response and resistance ;Primary end point(s): Progression-free survival;Timepoint(s) of evaluation of this end point: Every nine weeks or three chemotherapy cycles (three week cycles) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival, Objective response rate, Rate of non-progression at 9 and 18wks, Safety;Timepoint(s) of evaluation of this end point: Objective response rate: Every nine weeks or three chemotherapy cycles Rate of non-progression at 9 and 18wks: at 9 and 18wks of treatment Overall Survival, Safety: Continuosly | — |
Countries
Finland
Contacts
Public ContactJussi Koivunen
Oulu University Hospital
Outcome results
None listed