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    Participants who either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer.
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    These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
  • open for enrollment

    Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients with Recurrent Stage IV Squamous Cell Lung Cancer

    Protocol: SWOG-S1400

    Eligibility:

    Inclusion Criteria:

    SCREENING/PRE-SCREENING REGISTRATION:

    Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration; disease must be stage IV SCCA, or recurrent; the primary diagnosis of SCCA should be established using the current World Health Organization (WHO)/International Association for the Study of Lung Cancer (IASLC)-classification of Thoracic Malignancies; the diagnosis is based on hematoxylin and eosin (H&E) stained slides with or without specific defined immunohistochemistry (IHC) characteristic (p40/p63 positive, transcription termination factor [TTF1] negative) if required for diagnosis; mixed histologies are not allowed

    Patients must have adequate tumor tissue available, defined as >= 20% tumor cells and >= 0.2 mm^3 tumor volume; the local interpreting pathologist must review and sign off on the S1400 Local Pathology Review Form prior to screening/pre-screening registration; patients must agree to have this tissue submitted to Foundation Medicine for common broad platform Clinical Laboratory Improvement Amendments (CLIA) biomarker profiling; if archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained; a tumor block or FFPE slides 4-5 microns thick must be submitted; bone biopsies are not allowed; if FFPE slides are to be submitted, at least 12 unstained slides plus an H&E stained slide, or 13 unstained slides must be submitted; however it is strongly recommended that 20 FFPE slides be submitted; Note: previous next-generation deoxyribonucleic acid (DNA) sequencing (NGS) will be repeated if done outside this study for sub-study assignment

    Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment; patients will either consent to the screening consent or the pre-screening consent, not both; these criteria are:

    Screening at progression on prior treatment: to be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (stages I-IV); at least one of these lines of therapy must have been a platinum-based chemotherapy regimen; patients must have progressed following the most recent line of therapy; for patients whose prior systemic therapy was for stage I-III disease only (i.e. patient has not received any treatment for stage IV disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy

    Pre-screening prior to progression on current treatment: to be eligible for pre-screening, current treatment must be for stage IV disease and patient must have received at least one dose of the current regimen; patients must have previously received or currently be receiving a platinum-based chemotherapy regimen; patients on first-line platinum-based treatment are eligible upon receiving Cycle 1, Day 1 infusion; Note: patients will not receive their sub-study assignment until they progress and the S1400 Notice of Progression is submitted

    Patients must not have a known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion; EGFR/ALK testing is not required prior to registration and is included in the Foundation Medicine Incorporated (FMI) testing for screening/prescreening

    Patients must have Zubrod performance status 0-1 documented within 28 days prior to screening/pre-screening registration

    Patients must also be offered participation in banking for future use of specimens

    Patients must be willing to provide prior smoking history as required on the S1400 Onstudy Form

    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 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

    SUB-STUDY REGISTRATION:

    Patients whose biomarker profiling results indicate the presence of an EGFR mutation or echinoderm microtubule-associated protein-like 4 (EML4)/ALK fusion are not eligible

    Patients must have progressed (in the opinion of the treating investigator) following the most recent line of therapy

    Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration; patients must have recovered (=< grade 1) from any side effects of prior therapy; patients must not have received any radiation therapy within 14 days prior to sub-study registration

    Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI); the CT from a combined positron emission tomography (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 sub-study 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 sub-study 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 sub-study 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 prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study registration

    Patient must have fully recovered from the effects of prior surgery at least 14 days prior to sub-study 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 sub-study registration

    Platelet count >= 100,000 mcl obtained within 28 days prior to sub-study registration

    Hemoglobin >= 9 g/dL obtained within 28 days prior to sub-study registration

    Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to sub-study registration; for patients with liver metastases, bilirubin must be =< 5 x IULN

    Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to sub-study 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)

    Serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault Formula within 28 days prior to sub-study registration

    Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study 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: 1) have undetectable viral load using standard HIV assays in clinical practice, 2) have cluster of differentiation (CD)4 count >= 400/mcL, 3) not require prophylaxis for any opportunistic infections (i.e., fungal, Mycobacterium avium complex [mAC], or pneumocystis jiroveci pneumonia [PCP] prophylaxis), and 4) not be newly diagnosed within 12 months prior to sub-study registration

    Prestudy history and physical exam must be obtained within 28 days prior to sub-study 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 part of the 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 into 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.

    Principal Investigator: Erin M Bertino, MD

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  • open for enrollment

    Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

    Protocol: ALLIANCE-A151216

    Principal Investigator: Gregory A Otterson, MD

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  • open for enrollment

    The Effects of a Standardized Research E-Cigarette on the Human Lung:

    Protocol: OSU-18044

    Principal Investigator: Peter Shields, MD

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  • open for enrollment

    Phase I trial of PBF-1129 in patients with advanced Non-Small Cell Lung Cancer (NSCLC)

    Protocol: OSU-17270

    Principal Investigator: Dwight Owen, MD

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  • open for enrollment

    Sublobar Resection or Stereotactic Ablative Radiotherapy in Treating Patients with Stage I Non-small Cell Lung Cancer

    Protocol: OSU-15158

    Eligibility:

    Inclusion Criteria:

    Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

    Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities with a solid component of 50% or greater; those with ground glass opacities and < 50% solid component will be excluded

    Biopsy confirmed non-small cell lung cancer

    Tumor =< 4 cm maximum diameter, including clinical stage IA and selected IB by positron emission therapy (PET)/computed tomography (CT) scan of the chest and upper abdomen performed within 60 days prior to registration

    All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, endoscopic ultrasound (EUS)/endobronchial ultrasound (EBUS) guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy

    Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection

    Tumor located peripherally within the lung; NOTE: peripheral is defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions; patients with non-peripheral (central) tumors are NOT eligible

    No evidence of distant metastases

    Availability of pulmonary function tests (PFTs – spirometry, diffusing capacity of the lungs for carbon monoxide [DLCO], +/- arterial blood gases) within 90 days prior to registration; patients with tracheotomy, etc, who are physically unable to perform PFTs are potentially still eligible if a study credentialed thoracic surgeon documents that the patient’s health characteristics would otherwise have been acceptable for eligibility as a high risk but nonetheless operable patient (in particular be eligible for sublobar resection)

    Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria as described below:

    Major criteria

    • Forced expiratory volume in 1 second (FEV1) =< 50% predicted
    • DLCO =< 50% predicted

    Minor criteria

    • FEV1 51-60% predicted
    • DLCO 51-60% predicted
    • Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization
    • Poor left ventricular function (defined as an ejection fraction of 40% or less)
    • Resting or exercise arterial partial pressure of oxygen (pO2) =< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =< 88%
    • Partial pressure of carbon dioxide (pCO2) > 45 mm Hg
    • Study credentialed thoracic surgeon believes the patient is potentially operable but that a lobectomy or pneumonectomy would be poorly tolerated by the patient for tangible or intangible reasons
    • Modified medical research council (MMRC) dyspnea scale >= 3

    No prior intra-thoracic radiation therapy; NOTE: previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted so long as possible radiation fields would not overlap; previous chemotherapy or surgical resection specifically for the lung cancer being treated on this protocol is NOT permitted; no prior lung resection on the ipsilateral side

    Non-pregnant and non-lactating; women of child-bearing potential must have a negative urine or serum pregnancy test within 60 days prior to registration; peri-menopausal women must be amenorrheic >= 12 months prior to registration to be considered not of childbearing potential

    No prior invasive malignancy, unless disease-free for >= 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers)

    Ability to understand and the willingness to sign a written informed consent

    Principal Investigator: Terence M Williams, MD, PhD

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  • open for enrollment

    Osimertinib and Navitoclax in Treating Patients with EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer

    Protocol: OSU-16155

    Eligibility:

    Inclusion Criteria:

    Histologically confirmed non-squamous NSCLC, with incurable advanced or metastatic disease

    Prior genotyping positive for an EGFR activating mutation (L858R, exon 19 deletion, G719X, L861Q)

    Progression after prior treatment with an EGFR TKI; in addition to this one prior line of therapy, any additional prior lines of therapy are permitted; prior treatment with a third-generation EGFR TKI is allowed for the dose escalation phase, but is not permitted for the expansion cohort

    Adequate archival tissue from a biopsy performed after progression of disease on previous EGFR TKI; or willing to undergo a new tumor biopsy prior to registration (for the dose escalation portion only this requirement can be waived if T790M status has already been determined using a local assay)

    For the dose expansion portion only, patient must: 1) have a tumor which is EGFR-T790M positive using central genotyping (if EGFR-T790M status is unknown, patients may consent for central EGFR T790M testing as part of screening for the trial; patients who test negative for EGFR T790M by central genotyping will be ineligible), and 2) be treatment naive to T790M-directed EGFR TKI (e.g. AZD9291, rociletinib, etc)

    Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

    Any number of prior therapies are allowed

    Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

    Patients must have the ability to swallow oral dosage forms

    Life expectancy of greater than 3 months

    Leukocytes >= 3,000/mcL

    Absolute neutrophil count >= 1,500/mcL

    Hemoglobin >= 8.0 g/dL

    Platelets >= 100,000/mcL

    Activated partial thromboplastin time (aPTT), prothrombin time (PT) =< 1.2 × upper limit of normal (ULN)

    Total bilirubin =< 1.5 × ULN (patients with Gilbert’s syndrome may have serum bilirubin > 1.5 × ULN)

    Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 × institutional ULN

    Creatinine =< 2.0 mg/dL

    Creatinine clearance >= 50 mL/min

    Women of child-bearing potential and men must agree to use adequate contraception using one of the methods listed below prior to study entry, for the duration of study participation, and up to 90 days following completion of therapy:

    Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to study drug administration)

    Vasectomized male subject or vasectomized partner of female subjects

    Hormonal contraceptives (oral, parenteral, transdermal or vaginal ring) for at least 3 months prior to study drug administration; if the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 1 month after study completion

    Intrauterine device (IUD)

    Double-barrier method: male condom plus diaphragm or vaginal cap with spermicide (contraceptive sponge, jellies or creams)

    Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 90 days following completion of therapy

    Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment; women will be considered not of childbearing potential if they are surgically sterile (bilateral oophorectomy or hysterectomy) and/or post-menopausal (amenorrheic for at least 12 months)

    Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration

    Patients with a prior history of brain metastases are eligible provided:

    The brain metastases have been treated

    The patient is asymptomatic from the brain metastases

    Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days prior to registration

    The brain metastases are stable on pre-registration imaging

    Patients must have completed last chemotherapy >= 3 weeks or radiotherapy >= 2 weeks prior to receiving study drugs

    Patients must have recovered from adverse events attributable to previous treatment to =< grade 1, except for alopecia and sensory neuropathy =< grade 2

    Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:

    Major surgery within 21 days of starting protocol treatment

    Patients must discontinue previous EGFR-TKI at least 7 days prior to study enrollment

    Patients who are receiving any other investigational agents

    Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease

    Patients currently receiving (or unable to stop use at least 1 week prior to receiving the 1st dose of AZD9291) medications or herbal supplements known to be potent inhibitors of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) and potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; patients are eligible if they stop use of these compounds at least 1 week prior to receiving any treatment on this protocol

    Patients receiving anticoagulation or anti-platelet therapy are excluded; excluded agents include heparin or low molecular weight heparin, warfarin, clopidogrel, ibuprofen and other nonsteroidal anti-inflammatory drug (NSAIDS), tirofiban, and other anticoagulants, drugs, or herbal supplements that affect platelet function; administration of heparin to keep subject's infusion lines patent is allowed; low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter are allowed; aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention, may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (>= 50,000/mm3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor

    Patients with an underlying condition predisposing them to bleeding or currently exhibiting signs of clinically significant bleeding

    Patients with a recent history of non-chemotherapy-induced thrombocytopenic-associated bleeding within 1 year prior to the first dose of study drug

    Patients with a significant history of cardiovascular disease (e.g., myocardial infarction [MI], thrombotic or thromboembolic event in the last 6 months)

    Any of the following cardiac criteria:

    Mean resting corrected QT interval (QTc using Fredericia’s formula [QTcF]) > 470 msec

    Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block)

    Congenital long QT syndrome or family history of long QT syndrome

    Patients with active malignancies other than NSCLC or prior curatively treated malignancy at high risk of relapse during the study period with the exception of localized squamous or basal cell skin cancers

    Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, gastrointestinal disease limiting absorption of AZD9291 such as a malabsorption syndrome or inflammatory bowel disease or psychiatric illness/social situations that would limit compliance with study requirements

    Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with AZD9291 and navitoclax

    History of hypersensitivity to AZD9291 (or drugs with a similar chemical structure or class to AZD9291) or any excipients of these agents

    Patients with human immunodeficiency virus (HIV) on antiretroviral therapy are ineligible

    Principal Investigator: Erin M Bertino, MD

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  • open for enrollment

    Three Different Radiation Therapy Regimens in Treating Patients with Limited-Stage Small Cell Lung Cancer Receiving Cisplatin or Carboplatin and Etoposide

    Protocol: CALGB-30610

    Eligibility:

    Inclusion Criteria:

    Histologically or cytologically confirmed small cell lung cancer

    Limited stage disease patients, with disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes

    Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes are not eligible

    Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are not eligible unless they have a negative thoracentesis

    Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray, are not eligible

    Patients must have measurable disease, which includes lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan

    Patients may have received one and only one cycle of chemotherapy prior to enrolling on Cancer and Leukemia Group B (CALGB) 30610, which must have included carboplatin or cisplatin and etoposide; if a patient has had one cycle of cisplatin (or carboplatin)/etoposide prior to registration, the patient must have had all of the prior to registration tests prior to starting their first cycle of chemotherapy; additionally, these patients also must have met all of the eligibility criteria prior to receiving the first cycle of chemotherapy; registration to CALGB 30610 must take place within 14-21 days after the start of the non-protocol therapy; failing to do all of the above will make the patient NOT eligible for CALGB 30610

    No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for small cell lung cancer (SCLC)

    No prior mediastinal or thoracic radiotherapy

    Patients with complete surgical resection of disease are not eligible

    Eastern Cooperative Oncology Group (ECOG) performance status = 0-2

    No patients that are known to be pregnant or nursing

    Granulocytes >= 1,500/ul

    Platelet count >= 100,000/ul

    Total bilirubin =< 1.5 x upper limit of normal (ULN)

    Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.0 x ULN

    Serum creatinine =< 1.5 times ULN OR creatinine clearance >= 70 mL/min

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  • open for enrollment

    Hypofractionated Boost before Chemotherapy and Radiation Therapy in Treating Patients with Stage II or III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

    Protocol: OSU-14091

    Eligibility:

    Inclusion Criteria:

    All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) =< grade 1 (except alopecia) at the time of enrollment

    Absolute neutrophil count >= 1.5 x 10^9/L

    Hemoglobin >= 9 g/dL

    Platelets >= 100 x 10^9/L

    Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5; unless using warfarin for therapeutic anti-coagulation

    Albumin >= 2.5 g/dL

    Total bilirubin =< 1.5 x upper limit of normal (ULN)

    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN

    Creatinine =< 1.5 ULN AND

    Calculated creatinine clearance >= 50 mL/min (calculated by the Cockcroft-Gault formula) or

    24-hour urine creatinine clearance >= 50 mL/min

    Non-small cell lung cancer (NSCLC), histologically and/or cytologically proven

    Clinical American Joint Committee on Cancer (AJCC) stage (7th edition) IIA-IIIB NSCLC (T1-4N1-3M0)

    Patients must be considered unresectable or medically-inoperable

    Non-bulky lymphadenopathy =< 3 cm as defined by computed tomography (CT) largest axial diameter

    Patients must have primary tumor =< 6 cm as defined by CT largest axial dimension

    Within 4 weeks of registration: patients must have CT chest with IV contrast, fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)-CT scan (or CT abdomen/pelvis), and magnetic resonance imaging (MRI) brain with IV contrast (or CT head with contrast if contraindications to MRI); a non-contrast MRI chest or brain is permitted if patient has allergy to CT contrast or renal insufficiency

    Within 8 weeks of registration: pulmonary function tests (PFTs) including forced expiratory volume in one second (FEV-1) and diffusing capacity of the lung for carbon monoxide (DLCO)

    Within 2 weeks of registration: patients must have vital signs, history/physical examination, laboratory studies (complete blood count panel [CBCP] with differential, chemistries including liver function tests, creatinine clearance [CrCl] assessment, pregnancy test if needed)

    If a pleural effusion is present and visible on both CT scan AND chest x-ray, the investigator should exclude malignant disease by pleurocentesis to confirm cytologically-negative pleural fluid; if fluid is exudative or cytologically positive for tumor cells, patient is excluded

    Life expectancy of at least 12 weeks in the opinion of investigator

    Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

    Patients must be a minimum of 3 weeks from thoracotomy (if performed) and well-healed before starting treatment

    Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed

    Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the first administration of study treatment; urine human gonadotropin (HCG) is an acceptable pregnancy assessment

    Nursing women may participate only if nursing is discontinued

    Women/men of reproductive potential must be counseled on contraception/abstinence while receiving the study treatment

    Exclusion Criteria:

    Patients with contralateral hilar involvement (greater than 1.5 cm on short axis or positive on PET scan, or biopsy-proven)

    Documented or pathologically-proven metastatic disease

    Presence of nodules considered neoplastic in the same lobe as the primary tumor (stage T3), unless the nodule can be encompassed in the stereotactic boost (gross tumor volume [GTV]boost) without exceeding a total GTVboost size of 6 cm as defined by CT largest axial dimension

    Presence of nodules considered neoplastic in other ipsilateral lobes (stage T4) or contralateral lobes (M1a)

    Patients with history of pneumonectomy

    Prior cytotoxic chemotherapy or molecularly-targeted agents (e.g. erlotinib, crizotinib), unless > 2 years prior

    Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for >= 3 years will be allowed to enter the trial

    History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis

    History of previous radiation therapy to the chest which would result in overlapping fields

    History of allergic reaction to cisplatin or etoposide

    Uncontrolled neuropathy grade 2 or greater, regardless of cause

    Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

    Significant pre-existing hearing loss, as defined by the patient or treating physician

    Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator; this could include severe, active co-morbidities such as:

    Uncontrolled cardiac disease (hypertension, unstable angina, myocardial infarction within last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction)

    Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration

    Hepatic insufficiency resulting in jaundice and/or coagulation defects

    Principal Investigator: Terence M Williams, MD, PhD

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  • open for enrollment

    Crizotinib in Treating Patients with Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

    Protocol: ECOG-E4512

    Eligibility:

    Inclusion Criteria:

    Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or non-squamous IIIA NSCLC per American Joint Committee on Cancer (AJCC) 7th edition and have had negative margins; N3 disease is not allowed

    Baseline chest computed tomography (CT) with or without contrast must be performed within 6 months (180 days) prior to randomization to ensure no evidence of disease; if clinically indicated additional imaging studies must be performed to rule out metastatic disease

    Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

    Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization

    Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in echinoderm microtubule associated protein like 4 [EML4]-ALK fusion) as determined by the Vysis Break Point fluorescence in situ hybridization (FISH) assay and defined by an increase in the distance between 5’ and 3’ ALK probes or the loss of the 5’ probe; this must have been performed:

    By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory: report must indicate the results as well as the CLIA number of the laboratory which performed the assay; tissue must be available for submission for central, retrospective confirmation of the ALK fusion status via ALCHEMIST-SCREEN (ALLIANCE A151216) OR

    Patient registered to and the ALK fusion status performed centrally on the ALCHEMIST-SCREEN (ALLIANCE A151216)

    Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood or urine pregnancy test within 72 hours prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

    Women of childbearing potential and sexually active males must be strongly advised to practice abstinence or use an accepted and effective method of contraception

    Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

    No known interstitial fibrosis or interstitial lung disease

    No prior treatment with crizotinib or another ALK inhibitor

    No ongoing cardiac dysrhythmias of grade >= 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, uncontrolled atrial fibrillation (any grade), or corrected QT (QTc) interval > 470 msec

    No use of medications, herbals, or foods that are known potent cytochrome P450, subfamily 3A, polypeptide 4 (CYP3A4) inhibitors or inducers, included but not limited to those outlined

    Patients must be adequately recovered from surgery at the time of randomization

    The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days)

    The maximum time requirement between surgery and randomization must be:

    3 months (90 days) if no adjuvant chemotherapy was administered

    8 months (240 days) if adjuvant chemotherapy was administered

    10 months (300 days) if adjuvant chemotherapy and radiation therapy were administered

    Patients must have completed any prior adjuvant chemotherapy or radiation therapy 2 or more weeks (6 or more weeks for mitomycin and nitrosoureas) prior to randomization and be adequately recovered at the time of randomization

    NOTE: Patients taking low dose methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study

    NOTE: Neo-adjuvant chemotherapy or radiation therapy for the resected lung cancer is not permitted

    Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)

    Total serum bilirubin =< 1.5 x ULN

    Absolute neutrophil count (ANC) >= 1500/mm^3

    Platelets >= 30,000/mm^3

    Hemoglobin >= 8.0 g/dL

    Serum creatinine =< 2 x ULN

    Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy, or radiation must have recovered to grade =< 1 with the exception of alopecia and the criteria outlined

    Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer

    Patients may not be receiving any other investigational agents while on study

    Principal Investigator: Gregory A Otterson, MD

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  • open for enrollment

    Erlotinib Hydrochloride in Treating Patients with Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)

    Protocol: ALLIANCE-A081105

    Eligibility:

    Inclusion Criteria:

    Previously registered to A151216, with the result of lung cancer harboring an EGFR exon 19 deletion or L858R mutation; the testing must have been performed by one of the following criteria:

    a) Patient registered to A151216 and the assessment performed centrally by the protocol specified laboratory

    b) By a local Clinical Laboratory Improvement Amendments (CLIA) certified laboratory; the report must indicate the result as well as the CLIA number of the laboratory that performed the assay; these patients will also have been registered to A151216, but can be enrolled on A081105 regardless of the central lab results

    Patients with known resistant mutations in the EGFR tyrosine-kinase (TK) domain (T790M) are not eligible

    Patients that are both EGFR mutant and anaplastic lymphoma kinase (ALK) rearrangements will be registered to A081105

    Completely resected stage IB (>= 4 cm), II or IIIA non-squamous NSCLC with negative margins

    Complete recovery from surgery and standard post-operative therapy (if required); patients must be completely recovered from surgery at the time of randomization; the minimum time requirement between date of surgery and randomization must be at least 28 days, the maximum time requirement between surgery and randomization must be 90 days if no adjuvant chemotherapy was administered, 240 days if adjuvant chemotherapy was administered, and 300 days if adjuvant chemotherapy and radiation therapy was administered

    Eastern Cooperative Oncology Group (ECOG) performance status 0-1

    No prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma and in situ carcinomas

    Non-pregnant and non-lactating

    No history of cornea abnormalities

    Granulocytes >= 1,500/ul

    Platelets >= 100,000/ul

    Total bilirubin =< 1.5 x upper limit of normal (ULN)

    Serum glutamic oxaloacetic transaminase (SGOT) =< 1.5 x ULN

    Serum creatinine =< 1.5 x ULN

    Principal Investigator: Gregory A Otterson, MD

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