For more information regarding these studies, contact Cancer Research & Registry at (601) 984-1095.
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: Jennifer Eubanks, 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.
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.
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
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:
ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
ARM II: Patients are followed serially with imaging.
S1400: (Lung Map Study) Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Screening Step)
The purpose of this study screening step is to perform tests on genes and proteins produced by genes in your tumor sample for certain features that investigational targeted agents used in this study are specifically designed to work against. Then the purpose is to assign you to a treatment sub-study that is chosen based on the results (genes and proteins called “biomarkers”) of this genetic testing on your tumor sample. The system of assigning a treatment sub-study based on biomarker testing of cancer is investigational; in squamous cell lung cancer patients, we don't know whether testing can identify patients who will or will not benefit from treatment.
It may be possible that you will not be able to participate in the treatment part of this study. This could happen if it is unsafe for you to receive the investigational treatment. You may also choose to not participate in the treatment portion of the study.
S1400 G: A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)
***Must qualify for the S1400 Screening Study***
For this study, the tumor sample must have HRRD biomarker (homologous recombination repair deficiency), which make the cancer respond to a PARP inhibitor. If eligible, the patient will be assigned to treatment with talazoparib (BMN 673), a PARP inhibitor. The purpose of this sub-study is to find any good and bad effects of talazoparib (BMN 673). Talazoparib (BMN 673) may or may not shrink your cancer and it could also cause side effects.
S1400 I: (Lung Map Treatment Sub-Study A Phase III Randomized Study of Nivolumab Plus Ipilimumab Versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Treatment S1400I with Agent Ipilimumab Compared to Nivolumab)
***Must qualify for the S1400 Screening Study***
For this study, the tumor sample did not have a biomarker that matches one of the treatment studies or because the patient was not a candidate for a biomarker-matched treatment study.
This treatment study is testing a drug that works with the immune system to fight cancer. In this sub-study, patients are assigned to treatment with either nivolumab (the current standard of care) or to nivolumab combined with ipilimumab (the investigational therapy).
The purpose of this sub-study is to learn if the study drug (ipilimumab) will slow the cancer down. This study will allow the researchers to learn any good and bad effects of nivolumab combined with ipilimumab.
Principal Investigator: Jennifer Eubanks, MD
RTOG 3505: A Randomized, double blinded phase III trial of cisplatin and etoposide plus thoracic radiation therapy followed by nivolumab/placebo for locally advanced non-small cell lung cancer.
Patients with Stage III unresectable non-small cell lung cancer will receive thoracic radiation, cisplatin and etoposide followed by nivolumab or placebo given every 2 weeks for a year.
All patients will receive cisplatin and etoposide chemotherapy with radiation. After completion of chemoradiotherapy, eligible patients will be randomized to be in one of two groups: Group 1 will receive nivolumab and Group 2 will receive a placebo. The placebo will look the same as nivolumab, but it is a non-active substance and will have no effect on your cancer. This study will allow the researchers to know whether the addition of nivolumab is better, the same, or worse than the usual chemotherapy and radiation.
NRG-CC03: A Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer
This study is being done for small cell lung cancer that can spread to the brain. People who are not in a study are usually treated with radiation to the whole brain to reduce the chance of the cancer spreading to the brain.
The purpose of this study is to compare any good and bad effects of avoiding a part of the brain called the hippocampus (important for memory) during whole-brain radiation to the usual whole-brain radiation. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It also is possible that avoiding the hippocampus could have no benefit or could cause other side effects. Hippocampal avoidance also could lessen the effectiveness of whole-brain radiation.
This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.
The first portion of this study will test if avoiding the hippocampus during whole-brain radiation is as effective as the usual whole-brain radiation in decreasing the chance of cancer spreading to the brain. The second portion of the study will test if hippocampal avoidance decreases memory and thinking side effects.
CTSU/CALGB 30610: Phase III comparison of thoracic radiotherapy regimens in patients with limited small cell lung cancer also receiving cisplatin and etoposide
This study is being done to compare the effects, good or bad, of three different ways to give radiation therapy. Two of the ways are experimental, and one of them is standard.
Everyone will get chemotherapy with cisplatin and etoposide, which are standard chemotherapy drugs for this type of cancer. The exact doses for chemotherapy has not been completely standardized but participants will be receiving a commonly used dosing schedule. Using this dose of chemotherapy with any of the three radiotherapy regimens may cause additional side effects.
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