

Randomized Study of Erlotinib or VS Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)
Physician
Neil Belman, DO
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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.
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Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
Physician
Neil Belman, DO
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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:
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.
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A Randomized, Double-Blind, Placebo-Controlled Pilot Study Of An Oral, Selective Peripheral Opioid Receptor Antagonist In Advanced Non-Small Cell Lung Cancer
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Treatment Agent: Naloxegol
Synopsis: The purpose of this study is to test the safety and effects of naloxegol. Naloxegol is a medicine that blocks the actions of opioids outside the brain, without interfering with the pain-relieving effect of opioids inside the brain. The researchers want to see if naloxegol will relieve some of the side effects of the opioid pain medications you are taking. They also want to see if naloxegol fights off future growth in the cancer that you have, whether or not you are taking pain medications. The effect of two different doses of naloxegol will be compared to placebo.
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A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab plus Olaparib Combination Therapy Compared with Durvalumab Monotherapy as Maintenance Therapy in Patients whose Disease has not Progressed Following Standard of Care Platinum-Based Chemotherapy with Durvalumab in First-Line Stage IV Non-Small Cell Lung Cancer (ORION)
Physician
Neil Belman, DO
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Treatment Agent: Durvalumab, Olaparib
Synopsis: You are invited to take part in this research study because you have been diagnosed with lung cancer that has spread to other parts of the body (metastatic non-small cell lung cancer). The reason for the study is to find new, more effective treatment for your disease. Whether you take part or not is completely up to you. Take the time you need to read this information and ask your study doctor any questions. You can talk to your family, friends or family doctor before you decide. If you decide to take part, you must sign this form, to show that you agree to take part and to allow us to use your personal information.
AstraZeneca AB (AstraZeneca) is doing this research to find out the effectiveness of durvalumab combined with either olaparib or placebo (inactive ingredient) in treating patients with metastatic non-small cell lung cancer who have not had worsening of their cancer after treatment with durvalumab and chemotherapy.
This research study is designed to see if durvalumab given with olaparib will work better than durvalumab alone in treating this type of cancer as a maintenance treatment after durvalumab and chemotherapy. It will also determine whether the study drugs cause any side effects.
Both durvalumab (trade name ImfinziTM) and olaparib (trade name Lynparza™) are approved drugs by United States Food and Drug Administration (US FDA). Durvalumab is approved for patients with locally advanced or metastatic urothelial carcinoma whose cancers progressed during or after platinum-based chemotherapy and for Stage III non-small cell lung cancer, but not specifically for patients with metastatic non-small cell lung cancer. Durvalumab has also been approved by the FDA and the European Medicines Agency (EMA) for the treatment of patients with locally advanced non-small cell lung cancer after chemoradiation therapy. Olaparib is approved by the FDA and other countries. Olaparib is approved for certain patients with ovarian and breast cancer, but is not approved for lung cancer. Therefore, both durvalumab and olaparib are considered experimental treatments for patients with metastatic non-small cell lung cancer whose disease has not progressed (has not gotten worse) after first being treated with chemotherapy and durvalumab. Placebo will also be used in this study, and it will look like olaparib but will not contain any active medication.
Researchers have found that sometimes the body’s own immune system may slow down or control cancer growth. Sometimes this natural immune system response stops, and the cancer is not controlled by your own immune system. Research has shown that in some patients, cancer cells and immune cells start to express signals (Programmed Cell Death Ligand 1 = PD-L1 is one of them) that stop the body’s immune system from killing the cancer.
Durvalumab is an immunotherapy drug (a drug that targets a protein produced by the body’s defense system) that blocks PD-L1 signaling and the immune cells can once again attack the cancer and be able to prevent or slow down cancer growth. Durvalumab at 1500 mg will be administered by intravenous infusion every 3 weeks with chemotherapy (for a total of around 12 weeks), and every 4 weeks after that until you meet any treatment discontinuation criteria.
Meanwhile, researchers have also learned about the body's method to repair cells after damage. One method is through an enzyme found in the body called PARP (PARP=poly ADP ribose polymerase) which is responsible for repairing DNA/cells after damage. Olaparib is a PARP inhibitor. This means that olaparib stops PARP from working. Through blocking PARP, olaparib aims to block the repair of DNA in cancer cells, which can then cause the cancer cells to die. Also, there are also some lung cancers which contain mutations in genes that lead to incomplete repair of DNA called HRR genes [homologous recombination repair]. Recently researchers have shown that PARP inhibition can lead to tumor cell death in patients with altered DNA repair genes, and patients with HRR genes that are mutated may benefit even more from treatment with olaparib. Olaparib or placebo will be taken orally at 300mg twice a day if you make it into the maintenance phase of the study (after chemotherapy) until you meet any treatment discontinuation criteria.
If you decide to take part in this trial and if you have a specific type of lung cancer which is caused by certain genomic aberrations (genetic defect) including either ROS re-arrangement or BRAFV600E (names of specific genes) mutations, then you are choosing to forego approved therapies with demonstrated clinical benefits for cancers with these specific gene mutations.
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- Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation.
Patients must have tumors that lack activating EGFR mutations and ALK fusions.
Key Inclusion criteria for randomization to maintenance treatment:
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Exclusion criteria to be randomized to maintenance treatment:
• Inability to complete 4 cycles of platinum-based chemotherapy for any reason or discontinuation of Durvalumab during initial therapy.
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Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
Physician
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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.
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Individuals must meet all of the following inclusion criteria to be eligible for the study:
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Individuals will not be enrolled if 1 of the following exclusion criteria is met:
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A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
Physician
Neil Belman, DO
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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.
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Adjuvant Nivolumab in Resected Lung Cancers (ANVIL)-A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers
Physician
Neil Belman, DO
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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.
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