Erlotinib treatment beyound progressio

Phase 1

Conditions: ocally 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: 14.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 100000004864
MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-002049-13-FI

Lead Sponsor: Oulu University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 < 1’000/ul, Platelets < 100’000/ul, Alanine amino transferase < 2.5 x Upper limt of normal (ULN) (< 5 x ULN if liver metastases), Alkaline phosphatase < 2.5 x ULN (< 5 x ULN if liver metastases), Serum bilirubin < 1.5 x ULN, Serum Creatinine < 1.5 x ULN.
11.Patient must be able to comply with the protocol

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>Rate of non-progression at 9 and 18wks: at 9 and 18wks of treatment<br>Overall Survival, Safety: Continuosly