Lung-MAP: AZD4547 as Second-Line Therapy in Treating FGFR Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer

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 must be able to take oral medications; patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of AZD4547 (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• Patients must not have a history of hypersensitivity to active or inactive excipients of AZD4547 or drugs with a similar chemical structure or class to AZD4547
• Patients must not have any of the following ophthalmological criteria: current evidence or previous history of retinal pigmented epithelium detachment (RPED); previous laser treatment or intra-ocular injection for treatment of macular degeneration; current evidence or previous history of dry or wet age-related macular degeneration; current evidence or previous history of retinal vein occlusion (RVO); current evidence or previous history of retinal degenerative diseases (e.g. hereditary); or current evidence or previous history of any other clinically relevant chorioretinal defect
• Patients must have an eye exam performed within 28 days prior to sub-study registration; patients with uncontrolled glaucoma or intra-ocular pressure >= 21 mm Hg at screening should be referred for ophthalmological management and the condition controlled prior to registration
• Patients must have albumin, urinalysis, and Troponin I obtained within 7 days prior to sub-study registration
• Patients must have corrected calcium and phosphate = 21 mm Hg at screening should be referred for ophthalmological management and the condition controlled prior to crossover registration
• 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 substrates
• 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 Step 2 re-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
• Abso