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ProtocolTrial Name and Objective
031404

NRG ONCOLOGY (RTOG 1306): A RANDOMIZED PHASE II STUDY OF INDIVIDUALIZED COMBINED MODALITY THERAPY FOR STAGE III NON-SMALL CELL LUNG CANCER (NSCLC).

OBJECTIVES
Primary Objective:
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.
Secondary Objectives:
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.
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031501

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

Primary Objective:
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.
Secondary Objectives:
h 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.
h 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.
h Time To Death in evaluable set
Exploratory Objectives:
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
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051506

CLDK378A2112: Phase I, multi-center, randomized open label study to assess the systemic exposure and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC.)

Primary Objective:
To assess the steady-state PK of 450 mg or 600 mg ceritinib taken daily
with a low-fat meal as compared with that of 750 mg ceritinib taken daily in
the fasted state in patients with metastatic ALK-positive NSCLC.

Secondary objective:
To assess the safety profile (including frequency of patients with GI AEs by
severity and overall) of 450 mg or 600 mg ceritinib taken daily with a lowfat
meal as compared with that of 750 mg ceritinib taken daily in the fasted
state in patients with metastatic ALK-positive NSCLC

To assess the single-dose PK of 450 mg or 600 mg ceritinib taken daily
with a low-fat meal as compared with that of 750 mg ceritinib taken daily in
the fasted state in patients with metastatic ALK-positive NSCLC

To assess the antitumor activity of ceritinib as measured by objective
response rate (ORR) and duration of response (DOR) in patients with
metastatic ALK-positive NSCLC following oral dosing of 450 mg or 600 mg
ceritinib taken daily with a low-fat meal as compared with that of 750 mg
ceritinib taken daily in the fasted state
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051302

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)
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051304

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
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