Lung-MAP: AZD4547 as Second-Line Therapy in Treating FGFR Positive Patients With Recurrent Stage … (NCT02965378) | Clinical Trial Compass
CompletedPhase 2/3
Lung-MAP: AZD4547 as Second-Line Therapy in Treating FGFR Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer
United States43 participantsStarted 2014-10
Plain-language summary
This phase II/III trial studies how well FGFR inhibitor AZD4547 (AZD4547) works in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a sub-study that includes all screened patients positive for the fibroblast growth factor receptor (FGFR) biomarker. FGFR can cause tumor cells to grow more quickly. AZD4547 may decrease the activity of FGFR and may be able to shrink tumors.
Who can participate
Age range25 Years
SexALL
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Inclusion Criteria:
* Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
* Patients must be assigned to S1400D
* Patients must not be taking, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4 or CYP2D6 inhibitors and/or inducers
* Patients must not have received nitrosourea or mitomycin C within 42 days prior to sub-study registration
* Patients must not have had any prior exposure to any agent with FGFR inhibition as its primary pharmacology
* Patients must not have a mean resting corrected QT interval (QTc) \> 450 msec obtained from 3 consecutive electrocardiograms (ECGs); performed within 28 days prior to sub-study registration; patients must not have any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block); patients must not have any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age
* Patients must not be planning to receive any concomitant medication known to prolong QT interval
* Patients m…
What they're measuring
1
Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial)
Timeframe: From date of registration to maximum of 2 years and 4 months or death.