For more information regarding these studies, contact Cancer Research at (601) 984-1095.
A211401- Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes
The purpose of this study is to see if post-operative complications can be reduced by helping patients stop smoking with a drug called varenicline (also called Chantix®) and using National Cancer Institute Tobacco Quitline for counseling. This study will see how well the drug varenicline helps you stop smoking by comparing it to a placebo.
Principal Investigator: Jacob Moremen, MD
A151216 (Screening Study): Genetic Testing For Patients with Resectable or Resected Lung Cancer
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 the tumor is found to have one of these genetic changes, patients may be invited to participate on one of the ALCHEMIST trials that will look at drugs which may target tumors that have these specific genetic changes.
Principal Investigator: John Ruckdeschel, MD
A081105 (Treatment Study): Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)
***Must be registered to A151216 screening study*
This study is done for early stage non-small cell lung cancer that was surgically removed and may have been treated with chemotherapy and/or radiation. The purpose of this study is to compare any good and bad effects patients may have when treated with the standard treatment to those patients who are treated with the standard treatment plus erlotinib (an investigational drug).
As determined in the Screening study (A151216), the tumor removed has a mutation of a gene called EGFR (Epidermal Growth Factor Receptor). This study will try to determine if this mutation could help us make decisions about which type of treatment is best for people with this type of cancer.
Principal Investigator: John Ruckdeschel, MD
E4512 (Treatment Study): A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
***Must be registered to A151216 screening study ***
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.
This research study will allow the researchers to know whether this different approach is better, the same, or worse than 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 taking low dose Methotrexate for non-malignant conditions and other cytotoxic agents for non-malignant conditions are allowed to continue treatment while on study.
ALCHEMIST EA5142: 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
***Must be registered to A151216 screening study***
This randomized phase III trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal antibodies, such as nivolumab, may stimulate the immune system in different ways and kill tumor cells remaining after surgery and standard of care chemotherapy.
Patients are randomized to 1 of 2 treatment arms:
A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)
The purpose of this study is to find out if a targeted or immunotherapy treatment will have an effect on specific genes and proteins in the patients tumor.
The usual approach for patients who are not in a study is treatment with chemotherapy or immunotherapy drugs. Most patients, for example, will be treated first with cisplatin or carboplatin in combination with a second chemotherapy drug such as gemcitabine, paclitaxel, docetaxel, or vinorelbine. In addition, immunotherapy has been FDA approved for patients with previously untreated non-small cell lung cancer whose tumors have high expression of a marker called PD-L1, as well as for patients who previously received chemotherapy and then had progression of their cancer.
S1900A- A Phase II Study of Rucaparib in Patients with Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)
The purpose of this study is to find out if we can lower the chance of lung cancer growing or spreading by using a drug that targets a biomarker present in the tumor. We would like to see if this approach is better or worse than the usual approach for lung cancer.
The usual approach for patients who are not in a study is treatment with chemotherapy or immunotherapy drugs. If you have already received chemotherapy, other chemotherapy drugs or immunotherapy may be an option. If you have already received immunotherapy, chemotherapy may be an option. In addition, immunotherapy has been Food and Drug Administration (FDA) approved for patients with previously untreated non-small cell lung cancer whose tumors have high expression of a marker called PD-L1, as well as for patients who previously received chemotherapy and then had progression of their cancer.
A221504: A Randomized, Double-Blind, Placebo-Controlled Pilot Study Of An Oral, Selective Peripheral Opioid Receptor Antagonist In Advanced Non-Small Cell Lung Cancer (Adenocarcinoma)
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.
RRx-001-33: REPLATINUM: A Phase 3, Controlled, Open-label, Randomized Study of RRx-001 Administered Sequentially with a platinum doublet or a platinum doublet in third-line or beyond small cell carcinoma
This study will compare the impact of the addition of the study drug, RRx-001, to “platinum doublet” chemotherapy versus platinum doublet chemotherapy alone, which was a comparison that the FDA required at this stage of treatment, that is third-line or beyond. Cisplatin and carboplatin are types of platinum-based chemotherapies. These are combinations of chemotherapy drugs that contain derivatives of the metal platinum. The combination of cisplatin or carboplatin with another chemotherapy agent is called a “platinum doublet”, a term, which is used throughout, since the word doublet, refers to “a pair”. In this study, cisplatin or carboplatin will be combined with etoposide, which is an approved treatment for small cell cancer.
S1701, A Randomized Phase II Trial of Carboplatin-Paclitaxel with or Without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma
The purpose of this study is to compare any good and bad effects of using ramucirumab along with the usual chemotherapy combination (carboplatin and paclitaxel) to the usual chemotherapy combination alone. Ramucirumab is FDA-approved for non-small cell lung cancer but not for thymic cancer; however, ramucirumab in combination with carboplatin and paclitaxel is considered investigational and is not approved for this indication. Ramucirumab is a monoclonal antibody, a type of protein made in the laboratory that can bind to substances in the body, including cancer cells. Ramucirumab targets the vascular endothelial growth factor receptor 2 (VEGFR 2). VEGFR2 is an important molecule that supports the growth of blood vessels by a process called angiogenesis. Growth of these blood vessels can feed tumors and cause them to grow. Ramucirumab blocks VEGFR2 and may prevent angiogenesis in advance thymic tumor patients. This 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 approach should extend the amount of time you are cancer-free compared to the usual approach.