Lung-MAP: Palbociclib as Second-Line Therapy in Treating Cell Cycle Gene Alteration 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 S1400C
• Patients must not be taking within 7 days prior to sub-study registration, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment, strong CYP3A4 inhibitors and/or strong CYP3A4 inducers; moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution
• Patients must not be taking within 7 days prior to sub-study registration, nor plan to take while on protocol treatment drugs that are known to prolong the QT interval
• Patients must not have a screening corrected QT Fridericia?s formula (QTcF) interval > 480 msec based on the average of the triplicate electrocardiograms (EKGs) performed within 28 days prior to registration; NOTE: triplicate EKGs are required at other timepoints; patients must not have any family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or torsade de pointes
• 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 palbociclib (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• Patients must have a sodium (Na), potassium (K), chlorine (Cl), calcium (Ca), magnesium (Mg), and glycosylated hemoglobin measurement (HbA1c) performed within 7 days prior to sub-study registration
• Patients must also be offered participation in banking for future use of specimens
• STEP 2 PALBOCICLIB RE-REGISTRATION:
• Patients must have progressed on Arm 2 (docetaxel) of this sub-study
• Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to step 2 re-registration; patients must have recovered ( 480 msec based on the average of the triplicate EKGs performed within 28 days prior to step 2 re-registration; NOTE: triplicate EKGs are required at other timepoints; patients must not have any family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or torsade de pointes
• Absolute neutrophil count (ANC) >= 1, 500/mcl obtained within 28 days prior to step 2 re-registration
• Platelet count >= 100, 000 mcl obtained within 28 days prior to step 2 re-registration
• Hemoglobin >= 9 g/dL obtained within 28 days prior to step 2 re-registration
• Serum bilirubin = = 50 mL/min
• Patients must have a Na, K, Cl, Ca, Mg, and HbA1c performed within 7 days prior to sub-study registration
• Patients must have Zubrod performance status of 0-1 documented within 28 days prior to step 2 re-registration
• Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
• Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
• Patients with a known history of human immunodeficiency virus (HIV) seropositivity:
• Must have undetectable viral load using standard HIV assays in clinical practice
• Must have cluster of differentiation (CD)4 count >= 400/mcL
• Must not require prophylaxis for any opportunistic infections (i.e., fungal, mycobacterium avium complex [mAC], or pneumocystis pneumonia [PCP] prophylaxis)
• Must not be newly diagnosed within 12 months prior to re-registration
• Pre-study history and physical