Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Poziotinib in EGFR Exon 20 Mutant Advanced Non-Small Cell Lung Cancer (NSCLC)

Summary: The goal of this clinical research study is to learn if poziotinib can help to control EGFR-positive non-small cell lung cancer (NSCLC) that is locally advanced or metastatic (has spread). EGFR-positive NSCLC means that there is a mutation (a type of genetic change) on the EGFR gene.
  The safety of poziotinib will also be studied.

Detailed description: Study Drug Administration:
  Each study cycle is 28 days.
  If participant is found to be eligible to take part in this study, participant will take 2 poziotinib tablets by mouth 1 time every day while participant is on study. Each dose should be taken at about the same time each day (preferably in the morning) with a glass (about 8 ounces) of water.
  If participant misses a dose, participant should take it as soon as possible on the same day with a return to the normal schedule the following day. Participant should not take any extra doses on the following day to make up for any forgotten doses.
  Participant will be given a pill diary to complete. Participant should record in the diary each dose of poziotinib participant takes, including when participant took it. Participant should bring this diary with participant to each study visit.
  Length of Study:
  Participant may continue taking the study drug for as long as the doctor thinks it is in participant's best interest. Participant will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.
  Participation in this study will be over after follow-up.
  Study Visits:
  On Day 1 (+/- 7 days) of all cycles and Day 15 of Cycle 1:
  -  Participant will have a physical exam.
  -  Blood (about 2½ teaspoons) will be drawn for routine tests.
  At Week 16, participant will have an EKG. If participant's doctors thinks it is needed, participant may have additional EKGs during the study. Participant's doctor will discuss this with participant.
  At Month 3 and every 6 months after that, participant will have an ECHO or MUGA scan.
  Every 8 weeks, participant will have an CT scan and/or an MRI to check the status of participant's disease.
  Follow-Up Visit:
  About 30 days after participant's last dose of study drug:
  -  Participant will have a physical exam.
  -  Blood (about 2½ teaspoons) will be drawn for routine tests.
  -  Participant will have an EKG and either an ECHO or MUGA scan.
  Long Term Follow-Up:
  Every 6 months, participant will come to the clinic to have an ECHO or MUGA scan. During these visits participant will be asked how participant is doing and if participant has started any new drugs or treatment. If participant cannot come to the clinic, participant will be called by the study staff to answer these questions. Each call should last about 10 minutes.
  Participant will continue to have CT scans or MRIs every 8 weeks (+/- 14 days). If the disease appears to get worse, participant will stop having these scans.
  This is an investigational study. Poziotinib is not FDA approved or commercially available. It is being used for research purposes only. The study doctor can explain how the study drug is designed to work.
  Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility: Inclusion Criteria:
  1. Histologically or cytologically confirmed recurrent non-small cell lung cancer not amenable to curative intent therapy or stage IV NSCLC
  2. Documented EGFR exon 20 mutation by one of the following CLIA certified tests: OncoMine Comprehensive Assay (OCA), Guardant360 Assay (using plasma), or FoundationOne Assay or by an FDA approved device using cobas® EGFR mutation test v2 or therascreen EGFR RGQ PCt kit. Mutations include D770_N771insSVD, D770_N771insNPG, V769_D770insASV, H773_V774insNPH, or any other exon 20 in-frame insertion or point mutation excluding T790M.
  3. Patients must have progression of disease on or after a platinum-containing regimen. Multiple lines of therapy are allowed as long as previous therapy includes a platinum-containing regimen.
  4. Measurable disease by RECIST 1.1.
  5. Adequate tumor tissue obtained from a biopsy or surgical procedure to enable molecular profiling. If tissue is not available, the patient must have biopsy accessible disease and must be willing to undergo a biopsy.
  6. Age >/= 18 years.
  7. ECOG performance status 0 or 1.
  8. Ability to take pills by mouth
  9. Patients must have normal organ and marrow function as defined below: leukocytes >/= 3,000/mcL; absolute neutrophil count >/= 1,500/mcL; platelets >/= 100,000/mcL; hemoglobin >/= 9.0 g/dL; total bilirubin </= 2 x upper limit of normal (ULN); AST(SGOT)/ALT(SGPT)/Alkaline phosphatase </= 2.5 institutional upper limit of normal of </= 5 x ULN if liver metastases are present; creatinine clearance >/50 mL/min/1.73 m^2 by Cockcroft-Gault equation (creatinine clearance = ([140-age] x body mass/(plasma creatinine x 72) x gender correction factor) or by 24-hours urine collection
  10. Brain metastases are allowed, as long as they are stable and do not require treatment with anticonvulsants or escalating doses of steroids.
  11. Females of childbearing potential must have a negative serum or urine pregnancy test and must agree to use adequate contraception for the duration of the study and six months after. Adequate contraception methods include: birth control pills (eg combined oral contraceptive pill), barrier protection (eg condom plus spermicide, cervical/vault or intrauterine device), and abstinence. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Women will be considered post-menopausal if they have been amenorrheic for the past 12 months without an alternative medical cause. Inclusion Criterion cont'd in # 12.
  12. Continuation from inclusion criterion # 11: The following age-specific requirements must also apply: Women < 50 years old: they would be considered post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of exogenous hormonal treatments. The levels of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) must also be in the post-menopausal range (as per the institution). Women >/= 50 years old: they would be considered post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of all exogenous hormonal treatments, or have had radiation-induced oophorectomy with the last menses > 1 year ago, or have had chemotherapy-induced menopause with > 1 year interval since last menses, or have had surgical sterilization by either bilateral oophorectomy or hysterectomy.
  13. Non-sterilized males who are sexually active with a female partner of childbearing potential must use adequate contraception for the duration of the study and 90 days after the last dose of study medication. Adequate contraception methods include: birth control pills (eg combined oral contraceptive pill), barrier protection (eg condom plus spermicide, cervical/vault cap or intrauterine device), and abstinence.
  14. Ability to understand and the willingness to sign a written informed consent document.
  Exclusion Criteria:
  1. EGFR T790M mutation or any other acquired EGFR exon 20 mutation
  2. Have received or are receiving an investigational medicinal product (IMP) or other systemic anticancer treatment within 2 weeks prior to the first dose of study treatment.
  3. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
  4. Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and/or radiation, and has been stable without requiring escalating corticosteroids nor anti-convulsant medications for at least 4 weeks prior to the first dose of study medication.
  5. Known hypersensitivity to poziotinib or history of allergic reactions attributed to compounds of similar chemical or biologic composition to poziotinib.
  6. Cardiac conditions as follows: Patient has a history of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment. Patient has a cardiac ejection fraction <50% by either echocardiogram or multi-gated acquisition (MUGA) scan
  7. Have any unresolved chronic toxicity with CTCAE version 4.03 Grade >/= 2, from previous anticancer therapy, except for alopecia.
  8. Patient is unable to take drugs orally due to disorders or diseases that may affect gastrointestinal function, such as inflammatory bowel diseases (eg, Crohn's disease, ulcerative colitis) or malabsorption syndrome, or procedures that may affect gastrointestinal function, such as gastrectomy, enterectomy, or colectomy.
  9. Have any condition or illness that, in the opinion of the investigator, might compromise patient safety or interfere with the evaluation of the safety of the drug
  10. Pregnant or breastfeeding women
  11. History of another primary malignancy within 5 years prior to starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ
  12. Recent major surgery within 4 weeks prior to starting study treatment, with the exception of surgical placement for vascular access
  13. Male or female patients of reproductive potential who are not employing an effective method of birth control. Adequate contraception methods include: birth control pills (eg combined oral contraceptive pill), barrier protection (eg condom plus spermicide cervical/vault cap or intrauterine device), and abstinence.
  14. Uncontrolled intercurrent illness including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, active infection (including hepatitis B, hepatitis C, HIV, and active clinical tuberculosis), active bleeding diatheses or renal transplant; ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirements.

Relevance to patient case: possibly relevant