CompletedPhase 3NCT01828112

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

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.

Checked against the public recordLast updated Feb 7, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations97
SponsorNovartis Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Drug: Ceritinib; Drug: Pemetrexed; Drug: Docetaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 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. Exclusion Criteria: 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Highlands Oncology GroupFayetteville, Arkansas
  • Memorial Cancer InstituteHollywood, Florida
  • Cancer Specialists of North FloridaJacksonville, Florida
  • University Of MiamiMiami, Florida
  • Loyola University Medical CenterMarywood, Illinois
  • Uni Of Iowa Hospitals And ClinicsIowa City, Iowa
  • Massachusetts General HospitalBoston, Massachusetts
  • Oklahoma Cancer Specialists and Research InstituteTulsa, Oklahoma
  • Sarah Cannon Research InstituteNashville, Tennessee
  • Texas Oncology-SugarlandSugar Land, Texas
  • Texas Oncology Cancer Care and Research CenterWaco, Texas
  • Virginia Cancer SpecialistsFairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 7, 2025. Always confirm current availability with the study team.

View original record ↗