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Site for NRG-LU002: MAINTENANCE SYSTEMIC THERAPY VERSUS LOCAL CONSOLIDATIVE THERAPY (LCT) PLUS MAINTENANCE SYSTEMIC THERAPY FOR LIMITED METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC): A RANDOMIZED PHASE II/III TRIAL (PSCI# 21-028)
The purpose of this research study is to compare any good and bad effects of using the usual drug therapy plus radiation with or without surgery to treat the lung cancer and areas of metastasis (where the cancer has spread) compared with the usual drug therapy alone. Two types of radiation delivery will be used in this study. One type is called stereotactic body radiation therapy (SBRT) and will be used to treat areas of metastasis (parts of your body where the cancer has spread). SBRT uses special equipment to position a patient and precisely deliver radiation to tumors in the body. The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. The second type is standard radiation therapy and may be used to treat your primary lung tumor if SBRT cannot be used. Surgery also may be used to treat metastases or your primary lung tumor if you and your treating doctor decide this is a safe and better approach. Radiation, surgery, and usual drug therapy have already been tested for safety; however, using them in combination is not part of the usual approach. Adding radiation with or without surgery to the usual drug therapy could shrink or remove your tumor(s) or prevent the tumor(s) from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual therapy alone approach. Ultimately, to be better, the study treatment should increase life by six months or more compared to chemotherapy alone.
18 year(s) or older
Inclusion Criteria:Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration.
Age = 18;
Zubrod Performance Status 0, 1, or 2 within 30 days prior to registration;
Adequate organ and hematologic/bone marrow function within 14 days prior to registration
Negative serum pregnancy test within one week prior to registration for females of childbearing potential
Exclusion Criteria:Prior bevacizumab therapy is excluded.
Clinical or radiologic evidence of new, untreated, and/or progressive brain metastases prior to registration after induction systemic therapy
Cutaneous metastasis of NSCLC;
Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes if not a candidate for surgery for these lesions;
Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma of breast, oral cavity, skin, or cervix) unless disease free for a minimum of one year
Site for Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study) (PSCI# 19-079) (S1803)
This study is being done to answer the following questions: 1. Will adding the drug daratumumab/rHuPH20 to the usual maintenance treatment with lenalidomide after stem cell transplant help multiple myeloma patients survive longer? 2. For patients who have no evidence of multiple myeloma in their bone marrow (patients who do not have “minimum residual disease” [MRD-negative]), should maintenance therapy be stopped after 2 years? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.
18 year(s) or older
Inclusion Criteria:Patients must have had a confirmed diagnosis of symptomatic multiple myeloma (See Section 4.1) that required systemic induction therapy prior to autologous stem cell transplantation (ASCT).
Patients with disease measurable by serum light chain assay alone are eligible (defined as ≥ 100 mg/L on involved light chain).
Patients must be ≥ 18 and ≤ 75 years of age at time of registration to Step 1.
Patients must have history and physical exam within 28 days prior to registration.
Patients must have Zubrod Performance Status ≤ 2.
Exclusion Criteria:Patients with smoldering myeloma are not eligible
Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
Patients must not have progressive disease at any time prior to registration.
Patients must not be refractory or intolerant to either lenalidomide or daratumumab/rHuPH20.
Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.