Locally Advanced or Metastatic Non Small Cell Lung Cancer stage IIIb - IV
Conditions
Interventions
Product Name: selumetinib
Product Code: AZD6244 blue 25 mg capsule
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: selumetinib
CAS Number: 943332-08-9
Current Sponsor code: AZD2624 Hydrogen Su
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Provision of signed, written and dated informed consent prior to any study specific procedures Male or female, aged 18 years or older Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV) Prospective confirmation of KRAS mutation negative status as determined using the COBAS® KRAS Mutation Test (Roche Molecular Systems) via an AZ approved laboratory Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy 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 68 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 157
Exclusion criteria
Exclusion criteria: Mixed small cell and non-small cell lung cancer histology Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible. Having received an investigational drug within 30 days of first dose of study treatment or within five half-lives of the compound, or have not recovered from side effects of an investigational drug. Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment. Other concomitant anti-cancer therapy agents except steroids. Prior treatment with a MEK inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable) The last radiation therapy within 4 weeks prior to starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the efficacy of each comparison of selumetinib in combination with docetaxel, compared to placebo in combination with docetaxel, in terms of: OS, ORR, DoR, Change in tumour size at week 6 To assess the safety and tolerability profile for each treatment group To explore whether KRAS mutation status is predictive of efficacy of selumetinib in combination with docetaxel, compared with docetaxel alone To assess the effect on NSCLC symptoms for each comparison To assess the effect on health-related quality of life (HRQoL) for each comparison To investigate the pharmacokinetics (PK) of selumetinib and N-desmethyl selumetinib when administered in combination with docetaxel;Primary end point(s): To assess the efficacy in terms of Progression-Free Survival (PFS) for each comparison of selumetinib in combination with docetaxel, compared to placebo in combination with docetaxel;Timepoint(s) of evaluation of this end point: Patient's disease status is measured at baseline, every 6 weeks after start of treatment until objective disease progression or a discontinuation criterion is met ;Main Objective: To assess the efficacy in terms of Progression-Free Survival (PFS) for each comparison of selumetinib in combination with docetaxel, compared to placebo in combination with docetaxel | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the efficacy of each comparison of selumetinib in combination with docetaxel, compared to placebo in combination with docetaxel, in terms of: Overall Survival, Objective Response Rate, Duration of Response, Change in tumour size at week 6 To assess the safety and tolerability profile for each treatment group To explore whether KRAS mutation status is predictive of efficacy of selumetinib in combination with docetaxel, compared with docetaxel alone To assess the effect on NSCLC symptoms for each comparison To assess the effect on health-related quality of life (HRQoL) for each comparison To investigate the pharmacokinetics (PK) of selumetinib and N-desmethyl selumetinib when administered in combination with docetaxel;Timepoint(s) of evaluation of this end point: Patient´s disease status is measured at baseline, every 6 weeks after start of treatment until objective disease progression or a discontinuation criterion is met. Measured from consent, throughout the study and until a study discontinuation criterion is met KRAS mutation status will be confirmed prior to or as soon as possible after randomisation LCSS are to be completed from randomisation visit, every scheduled visit thereafter until 30 days post treatment discontinuation LCSS are to be completed from randomisation visit, every scheduled visit thereafter until 30 days post treatment discontinuation, the Short Form Health Survey - 36 Items (V2) has to be completed at randomisation visit and at week 3, week 12 and at treatment discontinuation pK samples taken on day 22 | — |
Countries
Brazil, Bulgaria, France, Germany, Hungary, Netherlands, Poland, United States
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed