Expanded Treatment Protocol With LDK378 in ALK(+) NSCLC
An Open-label, Multi-center, Expanded Treatment Protocol (ETP) of Oral LDK378 in Adult Patients With Non-small Cell Lung Cancer (NSCLC) Characterized by ALK Positivity
1 other identifier
expanded_access
N/A
10 countries
50
Brief Summary
Novartis-sponsored, open-label, multi-center, interventional ETP to provide LDK378 to patients with ALK (+)NSCLC, who have been pre-treated with an ALK inhibitor; except in countries where ALK inhibitors are not approved or available. The protocol will further evaluate the safety of LDK378 in patients with ALK(+) NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedNovember 3, 2020
December 1, 2019
September 17, 2013
November 1, 2020
Conditions
Interventions
750 mg. orally
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed diagnosis of NSCLC that demonstrates ALK positivity as assessed by approved FISH test (Abbott Molecular Inc), using Vysis breakapart probes (defined as 15% or more positive tumor cells); or the Ventana IHC test. If documentation of ALK positivity is not available, the test to confirm ALK positivity must be performed according to the above criterion, using a new tumor biopsy obtained prior to the first dose of ETP treatment (LDK378).
- Stage IIIB or IV NSCLC patient with documented disease progression at enrollment, and who does not qualify or have access to LDK378 through a clinical trial.
- Age 18 years or older at the time of informed consent.
- WHO performance status 0-3.
- Patients who have been pre-treated with an ALK inhibitor for locally advanced or metastatic NSCLC. Patients may be enrolled without prior exposure to an ALK inhibitor in countries where ALK inhibitors are not approved or available. Exposure to prior chemotherapy is not required.
- Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 2 (CTCAE v 4.03), provided that concomitant medication is given prior to initiation of treatment with LDK378. Exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment.
- The following laboratory criteria have been met:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Hemoglobin (Hgb) ≥ 8 g/dL
- Platelets ≥ 75 x 109/L
- Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN), except for patients with Gilbert's syndrome who may be included if total bilirubin ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
- Aspartate transaminase (AST) \< 3.0 x ULN, except for patients with liver metastasis, who are only included if AST \< 5 x ULN; alanine transaminase (ALT) \< 3.0 x ULN, except for patients with liver metastasis, who are only included if ALT \< 5 x ULN.
- Calculated or measured creatinine clearance (CrCL) ≥ 30 mL/min
- Patient must have the following laboratory values or have the following laboratory values corrected with supplements to be within normal limits at screening:
- Potassium ≥ LLN
- +5 more criteria
You may not qualify if:
- Patients with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate).
- Patients with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 1 week prior to ETP entry to manage CNS symptoms.
- Prior therapy with LDK378.
- The patient is less than 5 half-lives from prior ALK inhibitor or targeted therapy (for adequate wash-out) without recovery from treatment toxicities to ≤ grade 1 or to their pretreatment levels.
- Chemotherapy or an investigational therapy ≤ 3 weeks prior to starting the LDK378 treatment who have not recovered from side effects of such treatment toxicities to ≤ grade 2 or to their pre- treatment toxicities levels, with the exception of liver and cardiac functions which must be ≤ grade 1.
- Patients who have received thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs) radiotherapy ≤ 2 weeks prior to starting the LDK378 treatment or have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting LDK378 treatment is allowed.
- Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior (2 weeks for resection of brain metastases) to starting LDK378 treatment or who have not recovered from side effects of such procedures. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery, and patients can be enrolled in the ETP ≥ 2 weeks after the procedure.
- Patients with known history of extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention).
- Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as:
- unstable angina within 6 months prior to screening;
- myocardial infarction within 6 months prior to screening;
- history of documented congestive heart failure (New York Heart Association functional classification III-IV);
- uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 100 mm Hg, with or without antihypertensive medication -
- initiation or adjustment of antihypertensive medication(s) is allowed prior to screening;
- ventricular arrhythmias; supraventricular and nodal arrhythmias not controlled with medication;
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224, United States
Banner MDACC
Gilbert, Arizona, 85234, United States
Western Regional Medical Center, Inc.
Goodyear, Arizona, 85338, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Moores UCSD Cancer Center
La Jolla, California, 92093, United States
St Joseph Heritage Healthcare
Santa Rosa, California, 94503, United States
Stanford University
Stanford, California, 94305-5203, United States
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, 06360, United States
Advanced Medical Specialties
Miami, Florida, 33176, United States
Peachtree Hematology/Oncology Consultants
Atlanta, Georgia, 30309, United States
Emory University School of Medicine/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Indiana University Health Goshen Center for Cancer
Goshen, Indiana, 46526, United States
Johns Hopkins Bayview Hospital
Baltimore, Maryland, 21224, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, 20850, United States
Massachusetts General Hospital Mass General
Boston, Massachusetts, 02114, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Jackson Oncology Associates
Jackson, Mississippi, 39202, United States
Nebraska Cancer Specialist/Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Mercy Clinic Oklahoma Communities Mercy Oncology
Oklahoma City, Oklahoma, 73120-9391, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5820, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023, United States
University of Wisconsin
Madison, Wisconsin, 53705-2397, United States
Novartis Investigative Site
CABA, Buenos Aires, C1426ANZ, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires F.D., C1431FWO, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, 5000, Argentina
Novartis Investigative Site
Cali, Valle del Cauca Department, Colombia
Novartis Investigative Site
Montería, Colombia
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Kowloon, Hong Kong
Novartis Investigative Site
Delhi, 110 085, India
Novartis Investigative Site
Amman, 11941, Jordan
Novartis Investigative Site
Mexico City, Mexico City, 14080, Mexico
Novartis Investigative Site
Mexico D F, Mexico City, 06760, Mexico
Novartis Investigative Site
City of Taguig, National Capital Region, 1634, Philippines
Novartis Investigative Site
Quezon City, Philippines
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620, South Korea
Novartis Investigative Site
Gyeonggi-do, Korea, 10408, South Korea
Novartis Investigative Site
Seoul, Korea, 05505, South Korea
Novartis Investigative Site
Seoul, Korea, 06351, South Korea
Novartis Investigative Site
Seoul, Seocho Gu, 06591, South Korea
Novartis Investigative Site
Seoul, 03080, South Korea
Novartis Investigative Site
Seoul, 03722, South Korea
Novartis Investigative Site
Bangkok, 10330, Thailand
Novartis Investigative Site
Bangkok, 10400, Thailand
Novartis Investigative Site
Bangkok, 10700, Thailand