CompletedPhase 3NCT01828112
Official study title

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

Study 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. 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCeritinib and Pemetrexed

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · ALK

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?97 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

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

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

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