Back to resultsEfficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC
Primary Purpose
Non-Small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LGX818
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring NSCLC,, Non-Small Cell Lung Cancer,, BRAF V600,, LGX818
Eligibility Criteria
Inclusion Criteria:
- Presence of BRAF V600E mutation in tumor tissue
- Histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC
- At least one measurable lesion as defined by RECIST v1.1
- Patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic NSCLC.
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2
Exclusion Criteria:
- Patients with symptomatic Central Nervous System (CNS) metastases
- History of leptomeningeal metastases
- Prior therapy with a BRAF inhibitor
- Patients taking prohibited medication listed in the protocol
- Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
- Impaired cardiovascular function or clinically significant cardiovascular diseases
- Pregnant or lactating women or woman of childbearing potential
Sites / Locations
- University of Chicago Medical Center SC-2
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LGX818
Arm Description
Adult patients, with confirmed diagnosis of BRAF V600E mutant advanced or metastatic NSCLC who have progressed on or after at least one prior systemic anticancer therapy.
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator
Secondary Outcome Measures
Overall Response Rate (ORR)
ORR per RECIST 1.1 as assessed by by Blinded independent review committee (BIRC)
Progression-Free Survival (PFS)
PFS determined by investigator and BIRC.
Duration of Response (DOR)
DOR by investigator and BIRC assessments.
Overall survival (OS)
Overall survival (OS)
Safety Profile
Adverse events and laboratory abnormalities
Disease Control Rate (DCR)
DCR by investigator and BIRC assessments.
Pharmacokinetics profile
Plasma concentration-time profiles of encorafenib (LGX818).
Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay
Concordance rate between BRAF mutation status obtained using the investigational diagnostic test and the companion diagnostic assay which will be submitted for Pre-market approval (PMA)
Full Information
NCT ID
NCT02109653
First Posted
March 25, 2014
Last Updated
November 11, 2020
Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT02109653
Brief Title
Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC
Official Title
A Phase II, Single Arm, Open-label, Multicenter, Study of Oral LGX818 in Patients With BRAF V600 Mutant, Advanced Non-small Cell Lung Cancer (NSCLC) That Have Progressed During or After at Least One Prior Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study never started - transferred to Array.
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV) BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
NSCLC,, Non-Small Cell Lung Cancer,, BRAF V600,, LGX818
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LGX818
Arm Type
Experimental
Arm Description
Adult patients, with confirmed diagnosis of BRAF V600E mutant advanced or metastatic NSCLC who have progressed on or after at least one prior systemic anticancer therapy.
Intervention Type
Drug
Intervention Name(s)
LGX818
Intervention Description
Oral LGX818 300mg daily
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR per RECIST 1.1 as assessed by by Blinded independent review committee (BIRC)
Time Frame
baseline, every 6 weeks up to 24 weeks
Title
Progression-Free Survival (PFS)
Description
PFS determined by investigator and BIRC.
Time Frame
baseline, every 6 weeks up to 24 weeks
Title
Duration of Response (DOR)
Description
DOR by investigator and BIRC assessments.
Time Frame
baseline, every 6 weeks up to 24 weeks
Title
Overall survival (OS)
Description
Overall survival (OS)
Time Frame
baseline, every 6 weeks up to 24 weeks
Title
Safety Profile
Description
Adverse events and laboratory abnormalities
Time Frame
baseline, every 3 weeks up to 24 weeks
Title
Disease Control Rate (DCR)
Description
DCR by investigator and BIRC assessments.
Time Frame
baseline, every 6 weeks up to 24 weeks
Title
Pharmacokinetics profile
Description
Plasma concentration-time profiles of encorafenib (LGX818).
Time Frame
baseline, every 3 weeks up to 18 weeks
Title
Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay
Description
Concordance rate between BRAF mutation status obtained using the investigational diagnostic test and the companion diagnostic assay which will be submitted for Pre-market approval (PMA)
Time Frame
screening, up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of BRAF V600E mutation in tumor tissue
Histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC
At least one measurable lesion as defined by RECIST v1.1
Patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic NSCLC.
Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2
Exclusion Criteria:
Patients with symptomatic Central Nervous System (CNS) metastases
History of leptomeningeal metastases
Prior therapy with a BRAF inhibitor
Patients taking prohibited medication listed in the protocol
Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
Impaired cardiovascular function or clinically significant cardiovascular diseases
Pregnant or lactating women or woman of childbearing potential
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
1-800-718-1021
Official's Role
Study Director
Facility Information:
Facility Name
University of Chicago Medical Center SC-2
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60546
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC
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