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Clinical Trial

S1400, "Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer (Screening Step) Lung-MAP Sub-Study” (CTRC #14-0036)

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Clinical Trial

Vertebral Bone Marrow in Lung Cancer Attention Trial (VMAT) (CTMS# 21-0168)

The purpose of this study is to see whether designing radiation to spare the vertebral bone marrow can limit the rates of lymphopenia during standard of care chemoradiation therapy and in the time to count recovery in the ensuing weeks. Secondary endpoints will examine whether this leads to improved disease control whether this is predictive of improved clinical outcomes such as rates of local recurrence (LR), metastasis free survival (MFS), overall survival (OS), and progression free survival (PFS) which will be followed prospectively up to 5 years.

Clinical Trial

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and
Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab
in Patients With Previously Untreated, Locally Advanced Inoperable or
Metastatic Triple-Negative Breast Cancer, W

This is an international, multicenter, open-label, randomized, Phase 3 study in patients with locally advanced, inoperable, or metastatic triple-negative breast cancer (mTNBC) who have not received previous therapy for advanced disease and whose tumors are PD-L1 positive (defined using the PD-L1 IHC 22C3 assay as tumors with a combined positive score [CPS] ≥ 10) at screening.

Clinical Trial

daNIS-3: An Open-Label, Multi-Center, Phase II Platform Study Evaluating the Efficacy and Safety of NIS793 and Other New Investigational Drug Combinations With Standard of Care (SOC) Anti-Cancer Therapy for the Second Line Treatment of Metastatic Colorect

This study evaluates the preliminary efficacy and safety of NIS793 and other novel investigational combinations with SOC anti-cancer therapy vs SOC anti-cancer therapy for the second line treatment of metastatic colorectal cancer.