Lung-MAP: Taselisib as Therapy in Treating Patients With Stage IV Squamous Cell Lung Cancer and Positive Biomarker Matches
Condition: Recurrent Squamous Cell Lung Carcinoma; Stage IV Squamous Cell Lung Carcinoma
MeSH terms: Carcinoma; Lung Neoplasms
Intervention: Laboratory Biomarker Analysis; Taselisib
Intervention description: Correlative studies; Given PO
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well taselisib (GDC-0032) 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 phosphoinositide 3-kinase
      (PI3K) biomarker. PI3K can cause tumor cells to grow more quickly. Taselisib may decrease the
      activity of PI3K and may be able to shrink tumors.
    

Eligibility criteria:

        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 S1400B

          -  Hemoglobin A1c (HbA1c) < 7% obtained within 28 days prior to sub-study registration

          -  Fasting glucose < 125 mg/dL obtained within 28 days prior to sub-study registration

          -  Patients must not have type I or II diabetes that requires anti-hyperglycemic
             medication

          -  Patients must not have active or a history of small or large intestine inflammation
             such as Crohn's disease or ulcerative colitis

          -  Patients must not require daily supplemental oxygen

          -  Patients must be able to take oral medications; patients may not have any impairment
             of gastrointestinal function or gastrointestinal disease that may significantly alter
             the absorption of GDC-0032 (e.g. ulcerative disease, uncontrolled nausea, vomiting,
             diarrhea, malabsorption syndrome, or small bowel resection)

          -  Patients must not be taking, nor plan to take while on protocol treatment and for 14
             days post the last dose of study treatment, drugs, herbal supplements or foods that
             are known to be strong/moderate cytochrome p450, family 3, subfamily A, polypeptide 4
             (CYP3A4) substrates

          -  Patients must also be offered participation in banking for future use of specimens

          -  STEP 2 TO GDC-0032 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 (< grade 1) from any side effects of prior therapy

          -  Patients must have measurable disease documented by computed tomography (CT) or
             magnetic resonance imaging (MRI); the CT from a combined PET/CT may be used to
             document only non-measurable disease unless it is of diagnostic quality; measurable
             disease must be assessed within 28 days prior to step 2 re-registration; pleural
             effusions, ascites and laboratory parameters are not acceptable as the only evidence
             of disease; non-measurable disease must be assessed within 42 days prior to step 2
             re-registration; all disease must be assessed and documented on the baseline tumor
             assessment form; patients whose only measurable disease is within a previous radiation
             therapy port must demonstrate clearly progressive disease (in the opinion of the
             treating investigator) prior to registration

          -  Patients must have a CT or MRI scan of the brain to evaluate for central nervous
             system (CNS) disease within 42 days prior to step 2 re-registration; patient must not
             have leptomeningeal disease, spinal cord compression or brain metastases unless: (1)
             metastases have been locally treated and have remained clinically controlled and
             asymptomatic for at least 14 days following treatment, AND (2) patient has no residual
             neurological dysfunction and has been off corticosteroids for at least 1 day prior to
             re-registration

          -  Patients must not be planning to receive any concurrent chemotherapy, immunotherapy,
             biologic or hormonal therapy for cancer treatment; concurrent use of hormones for
             non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement
             therapy) is acceptable

          -  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 =< institutional upper limit of normal (IULN); for patients with liver
             metastases, bilirubin must be =< 5 x IULN obtained within 28 days prior to step 2
             re-registration

          -  Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN
             within 28 days prior to step 2 re-registration (if both ALT and AST are done, both
             must be < 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5
             x IULN (if both ALT and AST are done, both must be =< 5 x IULN)

          -  HbA1c < 7% obtained within 28 days prior to step 2 re-registration

          -  Fasting glucose < 125 mg/dL obtained within 28 days prior to step 2 re-registration

          -  Serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50
             mL/min

          -  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

          -  Prestudy history and physical exam must be obtained within 28 days prior to
             re-registration

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             stage I or II cancer from which the patient is currently in complete remission, or any
             other cancer from which the patient has been disease free for five years

          -  Patients must not be pregnant or nursing; women/men of reproductive potential must
             have agreed to use an effective contraceptive method; a woman is considered to be of
             "reproductive potential" if she has had menses at any time in the preceding 12
             consecutive months; in addition to routine contraceptive methods, "effective
             contraception" also includes heterosexual celibacy and surgery intended to prevent
             pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
             bilateral oophorectomy or bilateral tubal ligation; however, if at any point a
             previously celibate patient chooses to become heterosexually active during the time
             period for use of contraceptive measures outlined in the protocol, he/she is
             responsible for beginning contraceptive measures

          -  As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
             treating institution's identity is provided in order to ensure that the current
             (within 365 days) date of institutional review board approval for this study has been
             entered in the system

          -  Patients with impaired decision-making capacity are eligible as long as their
             neurological or psychological condition does not preclude their safe participation in
             the study (e.g., tracking pill consumption and reporting adverse events to the
             investigator)

          -  Patients must be informed of the investigational nature of this study and must sign
             and give written informed consent in accordance with institutional and federal
             guidelines