|Protocol||Trial Name and Objective|
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
ECOG E2511 Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib(ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer
This is a 2-part study consisting of a lead-in phase I dose escalation trial to establish the safety and
determine the optimal dose of veliparib (ABT-888) that will be safely combined with standard doses
of cisplatin and etoposide (CE). This will be followed by a randomized double blind phase II clinical
study to compare CE plus placebo against CE plus veliparib in patients with previously untreated
2.1 Phase I Primary Endpoints
To determine the recommended phase II dose (RP2D) of veliparib to use in combination with
2.2 Phase II Primary Endpoints
To determine whether the addition of ABT-888 to cisplatin etoposide (CE) results in
improved progression free survival (PFS) over CE with placebo in the frontline therapy of
newly diagnosed extensive stage small cell lung cancer
2.3 Phase II Secondary Endpoints
2.3.1 To determine the overall survival (OS) associated with the combination of CE plus
2.3.2 To assess the overall response rate (ORR) as well as complete response rate
(CRR) associated with the combination of CE plus ABT-888
2.3.3 To determine the toxicity profile of the combination of ABT-888 and CE
chemotherapy in this patient population.
2.3.4 To conduct exploratory correlative analysis of the impact of select biomarkers.
2.3.5 To compare the overall toxicity profile and specifically the incidence and severity of
chemotherapy-induced peripheral neuropathy with the addition of ABT-888 to CE
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
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.