|Protocol||Trial Name and Objective|
A novel class prediction algorithm for the analysis of nodules in NLST
The goal of the present study is to test and validate our proprietary class prediction algorithm (OncoCAD) to differentiate malignant nodules from benign nodules.
Aim 1: To develop an automatic CAD program to identify nodules from background signals.
We will use Insight Segmentation and Registration tool kit (ITK) and Medical visualization tool kit (VTK) for the Segmentation and visualization of the lungs.
Aim 2: To test our class prediction algorithm to discriminate among malignant nodules from benign nodules.
The voxel data obtain from CT scan image will be analyzed with our proprietary class prediction algorithm.
The Possible Role of ERCC1 in Determining Patterns of Recurrence after Chemoradiation for Lung Cancer
This study intends to characterize ERCC1 overexpression in predicting local recurrence of non-metastatic lung cancer and pancreas cancer treated with radiation therapy (RT) with or without chemotherapy. It is hypothesized that higher ERCC1 levels would allow for improved repair capacity and higher chance of local recurrence after radiation therapy
JNJ-42756493: A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493, a pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, in Subjects With Advanced or Refractory Solid Tumors or Lymphoma
1) To determine a safe and biologically active Phase 2 dose (recommended Phase 2 dose [RP2D]) for JNJ-42756493 (Part 1 Dose Escalation)
2) To evaluate the feasibility of treating a molecularly-defined subset of subjects with squamous celllung cancer and subjects with breast cancer with JNJ-42756493 at the RP2D (Part 2 Dose Expansion)
Phase IB Study of MK-3475 in Subjects with Select Advanced Solid Tumors
To evaluate preliminary signals of potential anti-tumor activity of MK-3475
in subjects with a given a histopathologic type of PD-L1 positive advanced solid tumor based on RECIST 1.1 as determined by the investigator in specific tumor indications
NRG ONCOLOGY (RTOG 1306): A RANDOMIZED PHASE II STUDY OF INDIVIDUALIZED COMBINED MODALITY THERAPY FOR STAGE III NON-SMALL CELL LUNG CANCER (NSCLC).
To assess whether patients with unresectable local-regionally advanced NSCLC treated with targeted agents based on molecular characteristics have a longer progression-free survival than those treated with standard care therapy alone.
To evaluate response rate;
To assess toxicity;
To assess overall survival;
To correlate clinical outcomes with tumor molecular aberrations identified from deep sequencing of selected kinomes in patients from whom adequate baseline tissue is available.
A Phase 1b/2 Dose Escalation and Expansion Trial of NC-6004 (Nanoparticle Cisplatin) plus Gemcitabine in Patients with Advanced Solid Tumors or Non-Small Cell Lung Cancer
The primary objectives of this study are:
In the dose-escalation phase of the study (Part 1), to determine the dose-limiting toxicities (DLTs) and MTD of NC-6004 in combination with gemcitabine;
In the expansion phase of the study (Part 2), to evaluate the activity, safety, and tolerability of NC-6004 in combination with gemcitabine in patients with relapsed (second- or third-line) squamous and nonsquamous Stage IIIB/IV NSCLC.
The secondary objectives of this study are:
To evaluate ORR, DCR, DOR, PFS, and OS
To evaluate therapy-related AEs
To evaluate QoL using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
To evaluate acute and delayed symptoms using the MD Anderson Symptom Inventory (MDASI) and a nausea and vomiting patient diary
The exploratory objectives of this study are:
To assess the PK and pharmacodynamic effects of NC-6004
A phase II trial of concurrent chemoradiation with consolidation Pembrolizumab (MK-3475) for the treatment of inoperable or unresectable stage III non-small cell lung cancer (NSCLC): LUN14-179
To determine if consolidation therapy with Pembrolizumab (MK-3475), following concurrent chemoradiation improves time to death or distant metastatic disease, depending on which occurs first, in patients with inoperable or unresectable stage IIIA or IIIB NSCLC. Distant metastasis is defined as anything that is outside of the radiation field.
To determine if consolidation therapy with Pembrolizumab (MK-3475), following concurrent chemoradiation improves progression free survival (PFS) and overall survival (OS) in patients with inoperable or unresectable stage IIIA or IIIB NSCLC.
To assess toxicity and tolerability of consolidation therapy with Pembrolizumab (MK-3475), following concurrent chemoradiation in patients with inoperable or unresectable stage IIIA or IIIB NSCLC.
Time To Death in evaluable set
To assess PD-L1 expression levels in the tumor samples of patients with inoperable or unresectable stage IIIA or IIIB NSCLC and correlate with time to distant metastatic disease, tumor histology, PFS, OS, and treatment toxicity
Asymmetric Cell Division and Notch Signaling in Lung Cancer Stem Cells
To determine if Notch signaling, chemokine signaling and epithelial-mesenchymal transition, or interactions between these pathways, regulate self-renewal of lung cancer stem cells.