LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib

Completed · Phase 3

Conditions studied: Non-Small Cell Lung Cancer

In brief

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. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), while also had the choice to continue with pemetrexed treatment.

Key facts

Study ID

NCT01828112

Run by

Novartis Pharmaceuticals

People needed

231

Starts

2013-06-28

Expected to finish

2023-11-10

Last updated by the study team

2025-02-07

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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
• Patients must have received previous treatment with crizotinib for the treatment of locally advanced or metastatic NSCLC.

You may not qualify if…

• Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
• Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
• 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.

Where it is running

• Memorial Cancer Institute — Hollywood, Florida, United States
• Cancer Specialists of North Florida — Jacksonville, Florida, United States
• University Of Miami — Miami, Florida, United States
• Loyola University Medical Center — Marywood, Illinois, United States
• Uni Of Iowa Hospitals And Clinics — Iowa City, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Oklahoma Cancer Specialists and Research Institute — Tulsa, Oklahoma, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Texas Oncology-Sugarland — Sugar Land, Texas, United States
• Texas Oncology Cancer Care and Research Center — Waco, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Edegem, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Marseille, Bouches Du Rhone, France
• Novartis Investigative Site — Besançon, France
• Novartis Investigative Site — Brest, France
• Novartis Investigative Site — Caen, France
• Novartis Investigative Site — Le Mans, France
• Novartis Investigative Site — Mulhouse, France
• Novartis Investigative Site — Paris, France
• Highlands Oncology Group — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.