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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01828112
First received: April 2, 2013
Last updated: June 23, 2014
Last verified: June 2014

April 2, 2013
June 23, 2014
June 2013
July 2017   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
PFS which is defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.
Same as current
Complete list of historical versions of study NCT01828112 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    OS defined as time from date of randomization to date of death due to any cause
  • Overall Response Rate (ORR) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    ORR is defined as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR); (CR+PR)
  • Duration of Response (DOR) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to underlying cancer
  • Disease Control Rate (DCR) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    DCR is defined as the proportion of patients with best overall response of CR, PR, or stable disease (SD)
  • Time to response (TTR) [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    TTR is defined as the time from date of randomization to date of first documented response (CR or PR)
Same as current
Not Provided
Not Provided
 
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: LDK378
    Oral LDK378 750 mg once daily
  • Drug: pemetrexed
    pemetrexed is 500 mg/m2 IV every 21 days
  • Drug: docetaxel
    docetaxel is 75 mg/m2 every 21 days
  • Experimental: LDK378
    Intervention: Drug: LDK378
  • Active Comparator: pemetrexed or docetaxel
    Interventions:
    • Drug: pemetrexed
    • Drug: docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
236
July 2017
July 2017   (final data collection date for primary outcome measure)

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

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.
Both
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Belgium,   Canada,   France,   Germany,   Hong Kong,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Russian Federation,   Singapore,   Spain,   Switzerland,   Turkey,   United Kingdom
 
NCT01828112
CLDK378A2303, 2012-005637-36
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP