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St. Luke's CenterAdministrative Offices
Lung Clinical Trials
Physician
Neil Belman, DO
Treatment Agent: Erlotinib
Synopsis: The purpose of this study is to compare any good and bad effects patients may have when treated with the standard treatment against patients who are treated with the standard treatment plus erlotinib (an investigational drug). You are being asked to take part in this research study because you have early stage non-small cell lung cancer that was surgically removed and may have been treated with chemotherapy and/or radiation. The tumor removed has a mutation of a gene called EGFR (Epidermal Growth Factor Receptor). We are trying to find out if this mutation could help us make decisions about which type of treatment is best for people with your type of cancer. People not in a research study are usually not treated with anything after they finish their chemotherapy although some of them may receive radiation therapy.
- 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:
- Patient registered to A151216 and the assessment performed centrally by the protocol specified laboratory
- 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.
- No interstitial fibrosis or lung disease
- 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
- 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
Physician
Neil Belman, DO
Treatment Agent: N/A
Synopsis: The purpose of this research study is to examine lung cancer patients’ surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes.
A genetic test will be done to learn if your tumor has any of these genetic changes. This test will look at the genetic material of the tumor cells. We are interested to see if your tumor tissue might have one of the following two genetic changes:
- Genetic changes in ALK (this will be referred to as ALK )
- Genetic changes in EGFR (this will be referred to as EGFR)
ALK and EGFR are both proteins found on the surface of cells. If your tumor is found to have one of these genetic changes you may be invited to participate na trial that will look at drugs which may target tumors that have these specific genetic changes. If your tumor is not found to have the genetic changes in ALK or EGFR, your doctor will provide you with other options for your care and you will be followed for 5 years. A doctor or research staff will contact you every 6 months for 5 years to determine the status of your cancer and your overall health. This will help doctors better understand what happens to patients receiving the standard treatment for the disease.
- Completely resected non-squamous NSCLC
- Pathologically staged IB >= 4 cm or stage IIA-IIIA disease
- Adequate formalin-fixed, paraffin-embedded (FFPE) tissue available for central EGFR and ALK genotyping for all patients, including those already identified to carry eligible EGFR or ALK alterations
- Clinical stage IB (>= 4 cm), II or IIIA non-squamous non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- No patients who have received neoadjuvant therapy (chemo- or radio-therapy)
- No interstitial fibrosis or lung disease
- No prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma or in situ carcinomas
- No prior treatment with agents targeting EGFR mutation or ALK rearrangement
- Non-lactating and no patients known to be pregnant
- No patients with local genotyping showing wild-type EGFR and ALK
- No patients with local genotyping showing a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation
- Completely resected non-squamous NSCLC
- Pathologically staged IB >= 4 cm or stage IIA-IIIA disease
- Adequate formalin-fixed, paraffin-embedded (FFPE) tissue available for central EGFR and ALK genotyping for all patients, including those already identified to carry eligible EGFR or ALK alterations
Physician
Sanjiv Agarwala, MD
Treatment Agent: N/A
Synopsis: The purpose of this study is to understand how nivolumab is used to treat patients who are diagnosed with advanced melanoma or lung cancer; and patients’ health-related experiences overall. Patients invited to participate are planning to start on nivolumab, either on its own or in combination with Ipilimumab as per routine care. The study will collect information about the patient’s health condition, how the patient is being treated with nivolumab and if there are any side effects from the treatment, and how the side effects are managed by the patient’s doctor. This study involves the collecting of information only and will not affect the treatment decision made by the patient’s physician. The data will be collected from the information previously recorded by the patient’s physician in the medical records, and future data that is collected by the patient’s doctor as part of routine care and treatment until the patient completes the study or withdraws consent. Participation in this study, the collected information and study results will help to understand how nivolumab is used and how best its side effects can be managed.
Individuals must meet all of the following inclusion criteria to be eligible for the study:
- Age >= 18
- Histologically or cytologically confirmed diagnosis of melanoma (including uveal
melanoma) or lung cancer - Treatment with commercial nivolumab for the first time, alone or in combination with ipilimumab, for the approved indications of nivolumab within 14 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy is determined before an informed consent to study participation, and treatment is initiated within 28 days after informed consent.
Individuals will not be enrolled if 1 of the following exclusion criteria is met:
- Prior participation in a clinical trial within the past 4 weeks.
- Previously treated with anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies.
- Previously treated with anti-CTLA-4 for lung cancer.
- Current or pending participation in a clinical trial.
- Current or pending systemic treatment for cancer other than melanoma and lung cancer.
- Inability to comply with the study protocol.
Physician
Neil Belman, DO
Treatment Agent: Crizotinib
Synopsis: The purpose of this research study is to compare any good and bad effects of using the study drug, crizotinib (also known as XALKORI®), after completion of surgery and, in some cases, after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer. The addition of crizotinib may help prevent your cancer from returning, but it could also cause side effects. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should improve how long you are able to live by 2 years and 9 months (33 months total) or more compared to the usual approach. The study drug, crizotinib, is already FDA-approved for use in ALK-positive locally advanced or metastatic (spread to other areas of the body) non-small lung cancer. The use of crizotinib in this study is investigational (not approved by the FDA) because crizotinib (or placebo) will be prescribed for earlier stage disease after the cancer has been surgically removed. A placebo is a capsule that looks like the study drug but contains no medication.
- Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II, or 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) must be performed within 3 months (90 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
- 6 months (180 days) if adjuvant chemotherapy was administered
- 8 months (240 days) if adjuvant chemotherapy and radiation therapy were administered
- Patients must have completed any prior 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
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =< 2.5="" x="" upper="" limit="" of="" normal="" />
- Total serum bilirubin =< 1.5="" x="" />
- Absolute neutrophil count (ANC) >= 1500/mm^3
- Platelets >= 30,000/mm^3
- Hemoglobin >= 8.0 g/dL
- Serum creatinine =< 2="" x="" />
- 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="" />
- Patients must not have any history of cancer within 2 years from randomization, with the exception of in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer
- Patients may not be receiving any other investigational agents while on study
Physician
Neil Belman, DO
Treatment Agent: Nivolumab
Synopsis: The purpose of this study is to find if adding the study drug, nivolumab (also known as OPVIDO®), will limit lung cancer from growing back in patients with early stage non-small cell lung cancer. Nivolumab is a drug that may turn on the body’s immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab may help prevent your cancer from returning, but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for lung cancer. The study drug, nivolumab, is already FDA-approved for use in non-small cell lung cancer that has previously been treated with chemotherapy. The use of nivolumab in this study is investigational (not approved by the FDA) in your type of cancer.
- Patients must have undergone complete surgical resection of their stage IB (>= 4 cm), II or IIIA NSCLC according to the American Joint Committee on Cancer (AJCC) 7th edition and have had negative surgical margins
- Baseline chest computed tomography (CT) must be performed within 1 month (30 days) of 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 0-1
- Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
- Non-squamous tumors must be epidermal growth factor receptor (EGFR) and anaplastic lymphoma receptor tyrosine kinase (ALK) wild-type (results ascertained in centrally as part of ALCHEMIST-SCREEN protocol)
- Tumors must have PD-L1 status tested centrally as part of the ALCHEMIST-SCREEN protocol
- Women must not be pregnant or breast-feeding
- All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration 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 use an accepted and effective method of contraception or to abstain from sexual intercourse during the treatment period and for 31 weeks after the last nivolumab infusion
- 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 situation that would limit compliance with study requirements
- No prior treatment with an immune checkpoint inhibitor (anti-programmed cell death [PD]-1, anti-PD-L1, anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA4] monoclonal antibody)
- Patients must have adequately recovered from surgery and chemotherapy at the time of randomization
- Minimum time between date of surgery and randomization is 4 weeks
- Maximum time allowed between surgery and randomization:
- 10 months if adjuvant chemotherapy and radiation therapy was administered
- 8 months if adjuvant chemotherapy was administered
- 3 months if no chemotherapy is administered
- Patients must have completed and recovered from any adjuvant chemotherapy 2 or more weeks prior to randomization (6 weeks for mitomycin and nitrosoureas; 4 weeks for post-operative radiation therapy)
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =< 2.5 x upper limit normal
- Total bilirubin =< 1.5 x upper limit of normal (ULN) (except in subjects with Gilbert syndrome who must have a total bilirubin < 3.0 x ULN)
- White blood cell (WBC) >= 2000/uL
- Neutrophils >= 1000/uL
- Platelets >= 100 x 10^3/uL
- Hemoglobin >= 8 g/dL
- Serum creatinine =< 2 x ULN
- Prior to randomization patients with any non-hematologic toxicity from surgery, chemotherapy and radiation therapy must have recovered to grade =< 1 with the exception of alopecia, ototoxicity and neuropathy
- Patients must not have any history of active malignancy within two years from randomization deemed by the investigator to pose a higher risk of recurrence than the lung cancer in question
- Patients must not be receiving any other investigational anti-cancer agents while on study
- Patients must not have known or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll
- Patients must not have a condition requiring systemic corticosteroids equivalent to > 10 mg prednisone per day or other immunosuppressive medications within 2 weeks of randomization
- Patients must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
- Patients must not have a known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is untreated and/or with a detectable viral load
- Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab
Physician
Neil Belman, DO
Treatment Agent: Nivolumab, Cisplatin/Carboplatin and Etoposide
Synopsis:This randomized phase II clinical trial studies whether the addition of nivolumab to cisplatin (or carboplatin) and etoposide will improve outcomes when treating patients with extensive stage small cell lung cancer. Drugs used in chemotherapy such as cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving cisplatin/carboplatin and etoposide together with nivolumab may work better in treating patients with extensive stage small cell lung cancer.
- Patients must have histologically or cytologically confirmed extensive stage small cell lung cancer and must be a candidate for systemic therapy; NOTE: The extensive disease SCLC classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy
- Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Absolute neutrophil count >= 1,500/mm^3 must be obtained =< 7 days prior to protocol registration
- Platelets >= 100,000/mm^3 must be obtained =< 7 days prior to protocol registration
- Leukocytes >= 3000/mm^3 must be obtained =< 7 days prior to protocol registration
- Hemoglobin >= 9 g/dL must be obtained =< 7 days prior to protocol registration
- Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dL) must be obtained =< 7 days prior to protocol registration
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 X institutional upper limit of normal (ULN) (=< 5 X if liver function test [LFT] elevations due to known liver metastases) must be obtained =< 7 days prior to protocol registration
- Serum creatinine =< 1.5 x ULN or calculated creatinine clearance > 50 mL/min (using the Cockcroft-Gault formula) must be obtained =< 7 days prior to protocol registration
- Patients are eligible if central nervous system (CNS) metastases are adequately treated and neurological symptoms have returned to baseline or are controlled for at least 2 weeks prior to enrollment; in addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of =< 10 mg daily prednisone (or equivalent); patients with untreated CNS metastases are eligible if they are not symptomatic and the lesions are less than 1 cm in size
- Patients cannot have had prior chemotherapy or biologic therapy for small cell lung cancer for front line treatment; patients receiving prior whole brain radiation cannot register within 7 days after completion of radiation, and must have resolved adverse events attributed to radiation to =< grade 1
- Patients who have received prior chemoradiation for limited-stage SCLC must have been treated with curative intent at least 6 months since last treatment from diagnosis of extensive-stage SCLC
- Patients may not be receiving any other investigational agents while on study
- Patients must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab or other agents used in the study
- Women must not be pregnant or breast-feeding; breastfeeding must be discontinued or the subject is not eligible for the study; all females of childbearing potential must have a blood test or urine study within 14 days prior to registration 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 (WOCBP) and males who are sexually active with WOCBP must use an accepted and effective method of contraception or abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment for women of childbearing potential and 7 months after the last dose of protocol treatment for males who are sexually active with WOCBP
- No prior or current invasive malignancy (except non-melanomatous skin cancer, localized bladder and prostate cancer) unless disease free for a minimum of 2 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
- No prior systemic treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways;
- Patient must not have leptomeningeal disease
- No patients with an active, known or suspected autoimmune disease and neuromuscular paraneoplastic syndromes including but not limited to myasthenia gravis, Lambert-Eaton myasthenic syndrome, limbic encephalitis, myositis, Guillain-Barre; subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
- No patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 7 days of randomization; inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
- No patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
- Patients must NOT have uncontrolled intercurrent illness including, but not limited to, 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
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
- Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection, patients are excluded
- Patients are ineligible if administration of a live, attenuated vaccine within 4 weeks before randomization
- No history of severe hypersensitivity reaction to any monoclonal antibody or allergy to study drug components;
