Carolinas HealthCare System

Research and Clinical Trials


Brief Description Principal Investigator
The primary objective of the study is to determine the efficacy of AP26113, as evidenced by objective response rate, in patients with ALK-positive locally advanced or metastatic NSCLC whose disease has progressed on therapy with crizotinib. Two dosing regimens will be tested. Induru, Raghava Reddy 
To evaluate progression free survival (PFS) with nab-paclitaxel as maintenance treatment after response or stable disease (SD) with nab-paclitaxel plus carboplatin in subjects with squamous cell NSCLC. Mileham, Kathryn Finch 
To assess the safety and tolerability of weekly continous nab-paclitaxel (Abraxane┬«) vs. with 1 week break in combination with Carboplatin as 1st line treatment for advanced NSCLC in elderly subjects >70 years old). Haggstrom, Daniel Ernest 
Celgene ABI-007-ST-001 Carrizosa, Daniel Ricardo 
The primary objective of this study is to evaluate the safety and tolerability of LY2835219 when administered orally in combination with multiple single-agent options to patients with Stage IV non-small cell lung cancer (NSCLC) using Common Terminology Criteria for Adverse Events (CTCAE version 4.0, NCI 2009). The secondary objectives of the study are to determine the pharmacokinetics (PK) of LY2835219 when given in combination with multiple single-agent options; to document the antitumor activ Kim, Edward Sanghyun 
To assess the safety and tolerability of the combination of PEGPH20 with docetaxel (PDoc).
To determine the recommended Phase 2 dose (RP2D) of PDoc.
To determine the recommended Phase 2 schedule of PDoc in subjects whose tumors have high levels of HA (high-HA).
Haggstrom, Daniel Ernest 
Primary objectives include: to determine a safe and biologically active Phase 2 dose (recommended Phase 2 dose [RP2D]) for JNJ-42756493 (Part 1 Dose Escalation); and to evaluate the feasibility of treating a molecularly-defined subset of subjects with squamous cell lung cancer and subjects with breast cancer with JNJ-42756493 at the RP2D (Part 2 Dose Expansion). Secondary objectives include: to evaluate the pharmacokinetics of JNJ-42756493; to evaluate pharmacodynamic and predictive biomarkers Chai, Seungjean 
To assess the response rate of the combination of carboplatin and abraxane in patients with advanced non-small cell lung cancer (NSCLC).
To assess the disease control rate, duration of response, duration of disease control, overall survival, progression-free survival, and the safety and toxicity profile with this regimen.
To assess broad molecular profiling.
Mileham, Kathryn Finch 
To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded independent central radiologists' review in subjects with PD-L1 strong, 1L metastatic NSCLC treated with MK-3475 compared to Standard of Care (SOC) Chemotherapies. Carrizosa, Daniel Ricardo 
This registry is intended to measure the effect of myPlan Lung Cancer? test has on influencing treatment decisions of Oncologists when added to standard clinical-pathological parameters in patients with early stage NSCLC.

Mileham, Kathryn Finch 
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