SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03586453

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Study of Osimertinib With On-study and Post-progression Biopsy in the First Line Treatment of EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

This research study is studying a targeted therapy as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation. The names of the study drug involved in this study is: - Osimertinib (Tagrisso)

NCT03586453 Carcinoma, Non-Small-Cell Lung
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: Osimertinib

Description: Patients who fulfill eligibility criteria will be entered into the trial to receive Osimertinib. After the screening procedures confirm participation in the research study: Osimertinib: Oral, Daily 28 day cycle. Radiographic assessment: every 2 cycles for first 6 months and then every 3 cycles until disease progression. Tumor biopsy between C4 and C8 and at disease progression
Type: Drug
Group Labels: 1

Osimertinib


Primary Outcomes

Description: Evaluated by comparing the genomic changes using targeted next generation sequencing in the post-osimertinib tumor to the pre-treatment tumor specimen.

Measure: Mechanisms of resistance to Osimertinib

Time: 4 Months

Secondary Outcomes

Description: Best objective response will be evaluated via RECIST 1.1 criteria. RECIST1.1 measurements of CT scans will be measured every 2 cycles on treatment to determine the objective response rate for patients being treated with osimertinib.

Measure: Best objective response

Time: 6 months

Description: Defined as the proportion of patients with best response of CR or PR per investigator assessment using RECIST 1.1. start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started.

Measure: Overall Response Rate

Time: 3 years

Description: Time from registration to documented disease progression or death from any cause, whichever occurs first. The Kaplan-Meier method will be used to determine the progression-free survival of patients enrolled on protocol and treated with combination osimertinib and selumetinib.

Measure: Progression-free survival (PFS)

Time: 2 years

Description: Survival follow-up with clinic visits or phone calls will be used to monitor for overall survival from time of study randomization to death from any cause. The Kaplan-Meier method will be used to calculate overall survival.

Measure: Overall survival

Time: 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

The Kaplan-Meier method will be used to calculate overall survival.. Inclusion Criteria: - Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory from tumor tissue. --- L858R ---

Inclusion Criteria: - Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory from tumor tissue. --- L858R ---


2 T790M

- cardiac ejection fraction of < 45% - Any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol - Known to be T790M+ (on pre-treatment tumor or plasma) or known germline T790M. --- T790M ---



HPO Nodes


HPO: