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Report for Clinical Trial NCT03414814

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II Study of Osimertinib in NSCLC Patients With EGFR Exon 20 Insertion Mutation

This is a single-arm, non-randomized multicentre phase 2 study in NSCLC patients with EGFR exon 20 insertion mutation, whose disease has progressed on standard chemotherapy.

NCT03414814 Locally Advanced or Metastatic NSCLC
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

1 Interventions

Name: Osimertinib 80 MG [Tagrisso]

Description: Osimertinib 80mg once daily until disease progression

Type: Drug

Osimertinib


Primary Outcomes

Description: Investigator-assessed, confirmed objective response by RECIST version 1.1

Measure: Objective response rate

Time: Through study completion, an average of 1 year

Secondary Outcomes

Description: AEs/SAEs as defined by NCI CTCAE version 4.0

Measure: Incidence of Treatment-Emergent Adverse Events

Time: Through study completion, an average of 1 year

Description: PFS as defined by RECIST version 1.1

Measure: Progression-free survival

Time: From date of initiation until the date of first documented progression, whichever came first, assessed up to 2 years

Description: OS as defined by RECIST version 1.1

Measure: Overall survival

Time: Through study completion, an average of 2 years

Description: Duration of response as defined by RECIST version 1.1

Measure: Duration of response

Time: Through study completion, an average of 1 year

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T790M

Osimertinib is an oral, potent, irreversible EGFR-TKI selective for sensitizing EGFR and EGFR T790M resistance mutations with a significant selectivity margin against wild-type EGFR. --- T790M ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1