SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03784599

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Trastuzumab-emtansine and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLC

This is a single arm open-label multi-center phase II study, investigating disease control rate after 3 months of treatment with trastuzumab-emtansine/osimertinib combination therapy in patients with advanced EGFR mutation positive non-small cell lung cancer (NSCLC) with HER2 bypass track resistance.

NCT03784599 Carcinoma, Non-Small-Cell Lung
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

2 Interventions

Name: Trastuzumab emtansine

Description: Infusion

Type: Drug

Trastuzumab-emtansine and osimertinib

Name: Osimertinib

Description: Tablet

Type: Drug

Trastuzumab-emtansine and osimertinib


Primary Outcomes

Description: Safety as indicated by intensity and incidence of adverse events, graded according to NCI CTCAE Version 4.03

Measure: Safety (intensity and incidence of adverse events)

Time: Up to 30 days after last study drug intake

Description: Complete response and partial response after 3 months of treatment

Measure: Objective response rate according to RECIST v1.1 after 3 months of treatment

Time: From date of registration until 3 months.

Secondary Outcomes

Description: PFS, defined as the time from first administration of the study drug combination to disease progression by RECIST v1.1. or lost to follow up or death, whichever comes first

Measure: Progression-free survival

Time: From date of registration until the date of first documented progression up to 100 months

Description: DCR, defined as the percentage of patients with stable disease (SD), partial response (PR) or complete response (CR)

Measure: Disease control rate, after 3 months of treatment

Time: From date of registration until 3 months.

Description: OS, defined as the time from first administration of the study drug combination to lost to follow up or death, whichever comes first

Measure: Overall survival

Time: From date of registration until the date of death from any cause, assessed up to 100 months.

Other Outcomes

Description: cfDNA samples will be collected to assess predictors of response and resistance

Measure: Genetic profiling to assess predictors of response and resistance - circulating free (cf)DNA

Time: At baseline, every 6 weeks and at treatment discontinuation (expected 6 months after start)

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T790M

3. A rebiopsy after having acquired resistance to a first, second or third generation TKI-treatment must have been performed and be: 1. Negative for T790M in case of treatment with a first or second generation EGFR TKI. --- T790M ---

After progression on a third generation EGFR TKI patients may either be positive or negative for T790M. --- T790M ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 2
TP53 BAP1