Non-small cell lung cancer MedDRA version: 18.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: LDK378
Pharmaceutical Form: Capsule
Current Sponsor code: LDK378
Other descriptive name: LDK378
Concentration unit: mg mil
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of stage IIIb or IV NSCLC that carries an ALK rearrangement as per the FDA-approved Vysis ALK break-apart FISH test (Abbott Molecular Inc) 2. Age 18 years or older at the time of informed consent. 3. Patients must have NSCLC that has progressed during or after the last chemotherapy regimen received prior to the first dose of LDK378, if chemotherapy was recieved. 4. Patients must be chemotherapy-naive or have received 1-3 lines of cytotoxic chemotherapy to treat their locally advanced or metastatic NSCLC 5. Patients must have archival tissue sample available, collected either at the time of diagnosis of NSCLC or any time since. 6. Patients must have recovered from all toxicities related to prior anticancer therapies to grade = 2 except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study Other protocol defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Prior treatment with crizotinib, or any other ALK inhibitor investigational agent, for NSCLC 2. Patients with know hypersensitivity to any of the excipients of LDK378 3. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms. 4. History of carcinomatous meningitis. 5. Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years. 6. Clinically significant, uncontrolled heart disease Other protocol defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the antitumor activity of LDK378, as measured by overall response rate (ORR) to LDK378 by investigator assessment;Primary end point(s): ORR per RECIST v1.1 calculated as the proportion of patients with a best overall response defined as complete response or partial response (CR+PR) as assessed by investigator;Timepoint(s) of evaluation of this end point: 6 cycles of 28 days up to 24 weeks; Secondary Objective: To evaluate response related endpoints as assessed by investigator and Blinded Independent Review Committee (BIRC): - Duration of response (DOR) - Disease control rate (DCR) - Time to response (TTR) To assess ORR by BIRC assessment To evaluate the safety profile of LDK378 To evaluate progression-free survival (PFS) To evaluate overall survival (OS) To evaluate overall intracranial response rate (OIRR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer, by investigator and BIRC assessment - DCR, calculated as the proportion of patients with best overall response of CR, PR, or SD, by investigator and BIRC assessment - TTR, calculated as the time from first dose of LDK378 to first documented response (CR+PR), by investigator and BIRC assessment - ORR (CR+PR) per RECIST v1.1 as assessed by BIRC - Adverse events and laboratory abnormalities - PFS, defined as time from first dose of LDK378 to progression or death due to any cause, as assessed by BIRC and investigator assessment - OS, defined as time from first dose of LDK378 to death due to any cause - OIRR, calculated as the ORR (CR+ PR) of lesions in the brain for patients who have measurable disease in the brain at baseline ;Timepoint(s) of evaluation of this end point: 6 cycles of 28 days up to 24 weeks for all | — |
Countries
Australia, Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Democratic People's Republic of, New Zealand, Norway, Russian Federation, Singapore, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States
Contacts
Public ContactMedical Collaboration Centre
Novartis Pharmaceuticals UK Ltd
Outcome results
None listed