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Report for Clinical Trial NCT02705339

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Genomic Landscape of EGFR Mutant NSCLC Prior to Rociletinib and at the Time of Disease Progression Following Rociletinib

Though patients whose tumors harbor EGFR T790M mutation appear to benefit from rociletinib, there is a need to understand the molecular mechanisms that lead to primary and acquired resistance to rociletinib. The investigators propose to conduct a clinical trial of rociletinib of patients with EGFR-mutant NSCLC with activating EGFR mutations (including exon 19 deletion or L858R mutation), with or without EGFR T790M mutation. In these patients, pre-treatment and post-progression biopsy specimens will be subjected to genomic analysis to fully understand the clonal evolution and the molecular mechanisms underpinning treatment resistance.

NCT02705339 Carcinoma, Non-Small-Cell Lung Non-Small Cell Lung Cancer Nonsmall Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

3 Interventions

Name: Rociletinib

Type: Drug
Group Labels: 1

Arm 1: Rociletinib

Name: Biopsy

Description: Standard of care biopsies will be taken at diagnosis and at the time of disease progression
Type: Procedure
Group Labels: 1

Arm 1: Rociletinib

Name: Blood draw

Description: -Approximately 4 teaspoons of blood will be drawn before treatment begins and at the time of disease progression to look at cell-free DNA
Type: Procedure
Group Labels: 1

Arm 1: Rociletinib


Primary Outcomes

Description: -The investigators plan to conduct exome and transcriptome sequencing of tumor before therapy with rociletinib and at the time of relapse. In addition, exome sequencing of peripheral blood DNA will be done (for germ line).

Measure: Somatic genetic changes in the tumor associated with disease progression

Time: Until the time of disease progression (estimated median of 3 months)

Secondary Outcomes

Description: ORR: Percentage of patients experiencing complete response or partial response Complete Response (CR): Disappearance of all target lesions and non-target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Measure: Overall response rate (ORR)

Time: Until the time of disease progression (estimated median of 3 months)

Measure: Overall survival (OS)

Time: Until death (estimated median of 8 months)

Description: -PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

Measure: Progression-free survival (PFS)

Time: Until the time of progression (estimated median of 3 months)

Measure: Duration of treatment

Time: Until the time of removal from study (estimated median of 3 months)

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

The investigators propose to conduct a clinical trial of rociletinib of patients with EGFR-mutant NSCLC with activating EGFR mutations (including exon 19 deletion or L858R mutation), with or without EGFR T790M mutation. --- L858R ---

Inclusion Criteria: - Histologically or cytologically confirmed metastatic stage IIIB/IV lung adenocarcinoma with known activating mutations in the EGFR TK domain (including exon 19 deletion and L858R) - Prior EGFR TKI therapy with progression, and documented EGFR T790M mutation on tumor biopsy; however, this need not be only second line - Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam. --- L858R ---


2 T790M

Rociletinib Genomic Landscape in Non-small Cell Lung Cancer (NSCLC) Though patients whose tumors harbor EGFR T790M mutation appear to benefit from rociletinib, there is a need to understand the molecular mechanisms that lead to primary and acquired resistance to rociletinib. --- T790M ---

The investigators propose to conduct a clinical trial of rociletinib of patients with EGFR-mutant NSCLC with activating EGFR mutations (including exon 19 deletion or L858R mutation), with or without EGFR T790M mutation. --- L858R --- --- T790M ---

Inclusion Criteria: - Histologically or cytologically confirmed metastatic stage IIIB/IV lung adenocarcinoma with known activating mutations in the EGFR TK domain (including exon 19 deletion and L858R) - Prior EGFR TKI therapy with progression, and documented EGFR T790M mutation on tumor biopsy; however, this need not be only second line - Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam. --- L858R --- --- T790M ---



HPO Nodes


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