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Research & Trial Information

SCHEMA EA5161

Protocol #: EA5161

Cancer Type: Small Cell Lung Cancer

Eligibility Criteria:

  1. Age 18 years.
  2. 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 with locally recurrent SCLC who are not eligible for curative intent chemoradiation are eligible.
  3. Patients must have measurable disease.
  4. ECOG performance status 0 or 1.
  5. Patients are eligible if CNS metastases are adequately treated and neurological symptoms have returned to baseline or are controlled for at least 2 weeks prior to enrollment.
  6. Patients cannot have had prior chemotherapy or biologic therapy for extensive stage 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. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
  7. Patients who have received prior chemoradiation treatment with chemotherapy regimen including cisplatin or carboplatin/etoposide for limited-stage SCLC are eligible if treated with curative intent at least 6 months since last treatment from diagnosis of extensive-stage SCLC.
  8. Patients may not be receiving any other investigational agents while on study.
  9. 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.
  10. 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).
  11. 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.
  12. Patient must not have leptomeningeal disease.
  13. 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-Barré. 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.
  14. 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.
  15. No patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
  16. 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.
  17. HIV-positive patients on combination antiretroviral therapy are ineligible.
  18. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection, patients are excluded.
  19. Patients are ineligible if administration of a live, attenuated vaccine within 4 weeks before randomization.
  20. No history of severe hypersensitivity reaction to any monoclonal antibody or allergy to study drug components.

 



Research & Trial Information

SCHEMA A221504

Protocol #: A221504

Cancer Type: Non Small Cell Lung Cancer

Eligibility Criteria:

  1. Advanced (stage IIIB or IV) lung adenocarcinoma diagnosed by biopsy of the primary or metastatic site.
  2. No known presence of known EGFR or EML4-ALK driver mutations in the tumor.
  3. Initiation of first-line chemotherapy with a platinum-pemetrexed-based regimen within 14 days of registration or planning to initiate within 14 days after registration. No planned initiation of definitive (potentially curative) concurrent chemo-radiation.
  4. No prior systemic therapy for advanced NSCLC, including chemotherapy, targeted therapy or immunotherapy. Prior palliative radiation permitted; prior adjuvant chemotherapy /radiation is permitted.
  5. No past or current use of mixed opioid agonist/opioid antagonists or other opioid antagonists.
  6. No methadone within 4 weeks prior to registration.
  7. Patients must have used opioid medication(s) for pain at some time in the 4 weeks prior to registration. Current use of opioids (at the time of registration) and/or later during the course of the study is permitted but not required.
  8. Expected survival > 3 months.
  9. No concurrently active second invasive malignancies except non-melanoma skin cancer.
  10. No history of gastrointestinal obstruction, or conditions that increase the risk of gastrointestinal obstruction, perforation, bleeding or impairment of the gastrointestinal wall. No abdominal surgery within 60 days of registration.
  11. No acute gastrointestinal conditions.
  12. No conditions that may compromise blood-brain barrier permeability (e.g., multiple sclerosis, recent brain trauma, Alzheimer’s disease, or uncontrolled seizures).
  13. No history of myocardial infarction ≤ 6 months prior to registration. No current symptomatic congestive heart failure, uncontrolled angina or uncontrolled cardiac arrhythmias.
  14. No severe hepatic impairment (Child-Pugh class C) or acute liver disease.
  15. No known serious or severe hypersensitivity reaction to naloxegol or any of its excipients.
  16. No concurrent use of moderate/strong CYP3A4 inhibitors, or strong CYP3A4 inducers.
  17. Age ≥ 18 years.
  18. ECOG Performance Status 0-2

 



Research & Trial Information

SCHEMA EA5152

Protocol #: EA5152

Cancer Type: Non Small Cell Lung Cancer

Eligibility Criteria for Step 0:

1.

    • · ROS1 gene rearrangement by FISH or DNA analysis (may have progressed on prior crizotinib therapy)
  • · MET exon 14 splice mutations on DNA analysis (may have progressed on prior crizotinib therapy)
  • · MET high amplification by FISH or DNA analysis or other MET mutations predicted to be sensitive to MET inhibitor (no prior targeted therapy allowed)
  • · RET gene rearrangement by FISH or DNA analysis (no prior targeted therapy allowed)

 

Patients with tumors with the following molecular alterations must submit testing results via Medidata Rave to determine eligibility to Arm T. The Study Chair, Co-Chair, Biology Co-Chair, or a delegate must review the molecular testing and agree that the testing meets eligibility outlined below (please see Section 4.2.4 for instructions):

Institutions will be notified of the patient’s eligibility status for Arm T within two (2) business days of submission of the molecular testing reports.

If patients do not have tumors with the above molecular alterations noted proceed directly to Step 1.

Eligibility Criteria for Step 1:

  1. For patients with known molecular alterations, institution has been notified that patient is deemed eligible for Arm T per review of molecular testing reports.
  2. Pathologically confirmed non-squamous non-small cell lung carcinoma (NSCLC).
  3. Stage IV disease (includes M1a, M1b, or recurrent disease).
  4. Predominant non-squamous histology (patients with NSCLC NOS are eligible). Mixed tumors will be categorized by the predominant cell type. If small cell elements are present the patient is ineligible.
  5. Tumors must be tested and known negative for EGFR TKI sensitizing mutations.
  6. Patients must have progressed radiographically following first line platinum-based chemotherapy, No additional lines of therapy are permitted.
  7. Patients must have measurable disease.
  8. No prior anti-MET therapy such as crizotinib or cabozantinib, or PD-1/PD-L1 immune checkpoint inhibitor therapy (such as nivolumab, pembrolizumab, atezolizumab) or CTLA4 inhibitor therapy (such as ipilimumab). No prior allergic reaction to small molecule tyrosine kinase inhibitors or monoclonal antibodies.
  9. Any prior chemotherapy (based on administration schedule) must have been completed in greater than or equal to the following times prior to registration: Chemotherapy/ targeted oral therapy administered in a daily or weekly schedule must be completed ≥ 1 week prior to registration; Any chemotherapy administered in an every 2 week or greater schedule must be completed ≥ 2 weeks prior to registration.
  10. No prior radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks prior to registration.
  11. Patients with no known brain metastasis must have baseline brain imaging within 12 weeks prior to study registration not demonstrating brain metastases.
  12. Patients must have ECOG performance status 0-1.
  13. Patients must have anticipated life expectancy greater than 3 months.

 

 



Research & Trial Information

SCHEMA EA5162

Protocol #: EA5162

Cancer Type: Non Small Cell Lung Cancer

Eligibility Criteria:

  1. Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC).
  2. Participants must have advanced disease – either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease.
  3. An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any CLIA-certified tissue assay.
  4. Patients must have measurable disease.
  5. Patients must have previously received at least one line of therapy for their advanced lung cancer. There are no restrictions on the maximum number of prior therapies allowed.
  6. Participants may not have received any prior treatment with therapies targeting PDL1, PD1 or CTLA4.
  7. Age ≥ 18 years.
  8. ECOG performance status ≤1.
  9. Participants may not have clinically active or symptomatic interstitial lung disease or interstitial pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention), or a history of clinically significant interstitial lung disease or radiation pneumonitis.
  10. Participants may not have had radiation to the lung fields within four weeks (28 days) of starting treatment. For patients receiving palliative radiation to thoracic vertebrae, ribs or other sites where the radiation field includes the lungs, radiation must be completed at least two weeks before starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting to treatment. At least six months (180 days) must have elapsed from radiation given with curative intent.
  11. Participants may not have clinically symptomatic brain metastases or leptomeningeal disease. Patients may be on a stable dose of corticosteroids to control brain metastases if they have been on a stable dose for two weeks (14 days) prior to study treatment and are clinically asymptomatic.
  12. Patients must have an ECHO or a nuclear study (MUGA or First Pass) within 4 weeks (28 days) prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be > 50% for the patient to be eligible.
  13. No history of QT prolongation associated with other medications that required discontinuation of that medication. Patient must not be receiving any concomitant medications that are known to be associated with Torsades de Pointes. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block, second degree heart block, Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval. Symptomatic heart failure – New York Heart Association (NYHA) grade II-IV.
  14. Participants may not have a second, clinically active, cancer. Patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed.
  15. Participants may not be receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least two weeks or five half-lives, whichever is longer, before starting treatment.
  16. Participants may not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirement.

 


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