SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02109653

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02109653 Non-Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: LGX818

Description: Oral LGX818 300mg daily
Type: Drug
Group Labels: 1

LGX818


Primary Outcomes

Description: ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator

Measure: Overall Response Rate (ORR)

Time: up to 24 weeks

Secondary Outcomes

Description: ORR per RECIST 1.1 as assessed by by Blinded independent review committee (BIRC)

Measure: Overall Response Rate (ORR)

Time: baseline, every 6 weeks up to 24 weeks

Description: PFS determined by investigator and BIRC.

Measure: Progression-Free Survival (PFS)

Time: baseline, every 6 weeks up to 24 weeks

Description: DOR by investigator and BIRC assessments.

Measure: Duration of Response (DOR)

Time: baseline, every 6 weeks up to 24 weeks

Description: Overall survival (OS)

Measure: Overall survival (OS)

Time: baseline, every 6 weeks up to 24 weeks

Description: Adverse events and laboratory abnormalities

Measure: Safety Profile

Time: baseline, every 3 weeks up to 24 weeks

Description: DCR by investigator and BIRC assessments.

Measure: Disease Control Rate (DCR)

Time: baseline, every 6 weeks up to 24 weeks

Description: Plasma concentration-time profiles of encorafenib (LGX818).

Measure: Pharmacokinetics profile

Time: baseline, every 3 weeks up to 18 weeks

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)

Measure: Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay

Time: screening, up to 24 weeks

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 V600E

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. --- V600E ---

- Impaired cardiovascular function or clinically significant cardiovascular diseases - Pregnant or lactating women or woman of childbearing potential 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. --- V600E ---



HPO Nodes


HPO: