Summary

for people ages 18 years and up (full criteria)
at UCSF
study started
estimated completion:

Description

Summary

The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib.

Official Title

A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib

Keywords

Non-Small Cell Lung Cancer ALK LDK378 Non-small cell lung carcinoma (NSCLC) treatment of lung cancer after first metastasis lung cancer lung adenocarcinoma Non small cell lung carcinoma Non small cell lung cancer NSCLC chemotherapy ALK-positive ALK-rearranged advanced non-small cell lung cancer crizotinib Lung Neoplasms Carcinoma, Non-Small-Cell Lung Docetaxel Ceritinib Pemetrexed

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patient has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by the FDA approved Abbott FISH Test.
  2. Patient has stage IIIB or IV diagnosis and must have received one or two prior regimens (including platinum- doublet) of cytotoxic chemotherapy for the treatment of locally advanced or metastatic NSCLC.
  3. Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
  4. Patients must have received previous treatment with crizotinib for the treatment of locally advanced or metastatic NSCLC.

You CAN'T join if...

  1. Patient with known hypersensitivity to any of the excipients of LDK378(microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
  2. Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
  3. Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.

Locations

  • UCSF Medical Center Dept. of UCSF
    San Francisco California 94143 United States
  • Arizona Oncology Associates PC- HAL
    Sedona Arizona 86336 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT01828112
Phase
Phase 3
Study Type
Interventional
Last Updated