E-Newsletter - September 2021
Spotlight on Recently Activated Trials


Alliance A021901
Randomized phase II trial of lutetium Lu 177 dotatate versus everolimus in somatostatin receptor positive bronchial neuroendocrine tumors

Study Chair: Thomas Hope, MD, University of California San Francisco
Activated: 09/10/2021  Status: Now recruiting participants
CT.gov Link: https://bit.ly/Alliance-A021901

Overview: This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.


Alliance A051902
A randomized phase II study of CHO(E)P vs. oral azacitidine-CHO(E)P vs. duvelisib-CHO(E)P in previously untreated CD30 negative peripheral T-cell lymphomas

Study Chair: Neha Mehta-Shah, MD, Washington University School of Medicine
Activated: 07/30/2021
CT.gov Link: https://bit.ly/Alliance-A051902

Overview: This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help find out if this approach is better or worse than the usual approach for treating peripheral T-cell lymphoma.


Alliance A031902
CASPAR - A phase III trial of enzalutamide and rucaparib as a novel therapy in first-line metastatic castration-resistant prostate cancer

Study Chair: Arpit Rao, MD, University of Minnesota
Activated: 02/19/2021 
CT.gov Link: http://bit.ly/Alliance-A031902

Overview: This randomized, placebo-controlled phase III trial evaluates the benefit of rucaparib and enzalutamide combination therapy versus enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-deprivation therapy (castration-resistant). Enzalutamide helps fight prostate cancer by blocking the use of testosterone by the tumor cells for growth. Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as rucaparib, fight prostate cancer by prevent tumor cells from repairing their DNA. Giving enzalutamide and rucaparib may make patients live longer or prevent their cancer from growing or spreading for a longer time, or both. It may also help doctors learn if a mutation in any of the homologous recombination DNA repair genes is helpful to decide which treatment is best for the patient.


Alliance A011801
The CompassHER2 trials (Comprehensive use of pathologic response assessment to optimize therapy in HER2-positive breast cancer) CompassHER2 residual disease (RD), a double-blinded, phase III randomized trial of T-DM1 compared with T-DM1 and tucatinib

Study Chair: Ciara C. O'Sullivan, MB, BCh, BAO, Mayo Clinic
Activated: 1/06/2021
CT.gov Link: https://bit.ly/Alliance-A011801

Overview: This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.



For other articles in this issue of the Alliance E-News newsletter, see below.