SNPMiner Trials by Shray Alag


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Report for Clinical Trial NCT02736513

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Pilot, Phase 2 Study Assessing Intracranial Activity of AZD9291 (TAGRISSO) in Advanced EGFRm NSCLC Patients With Asymptomatic Brain Metastases

Patients will receive AZD9291 at a dose of 80 mg once daily. Intracranial response will be assessed with brain MRI scan, systemic evaluation will be done by PET-CT scan. In case of isolated CNS progression which may or may not be accompanied by asymptomatic systemic progression, AZD9291 dose will be escalated to 160 mg once daily. For patients whose intracranial disease will progress further, brain radiotherapy (in the form of SRS or WBRT) will be administered; treatment with AZD9291 will be interrupted and re-initiated at a standard dose after the end of radiotherapy course in the absence of symptomatic systemic progression. The treatment will be continued until symptomatic systemic progression, unacceptable toxicity or further intracranial progression following brain radiotherapy administration (whichever occurs first). All patients will be followed until death or 5 years.

NCT02736513 Lung Cancer
MeSH: Neoplasm Metastasis

1 Interventions

Name: AZD9291

Description: Patients will receive AZD9291 at a dose of 80 mg once daily.

Type: Drug

AZD9291 80 mg - naive patients AZD9291 80 mg - previously treated


Primary Outcomes

Description: Patients will receive TAGRISSO. Intracranial response will be assessed with brain MRI scan, systemic evaluation will be done by PET-CT scan.

Measure: Intracranial overall response rate as defined by modified RECIST

Time: 5 years

Secondary Outcomes

Measure: Intracranial disease control rate (IDCR) as defined by mRECIST

Time: 5 years

Measure: median time to intracranial response (mTTIR) as defined by mRECIST

Time: 5 years

Measure: median intracranial progression free survival (mIPFS) as defined by mRECIST

Time: 5 years

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

- Exon 19 deletion, L858R, T790M and uncommon sensitizing EGFR mutations in treatment-naïve patients are allowed. --- L858R ---


2 T790M

- Exon 19 deletion, L858R, T790M and uncommon sensitizing EGFR mutations in treatment-naïve patients are allowed. --- L858R --- --- T790M ---

erlotinib or afatinib) in whom T790M was diagnosed in the tumor specimen or ctDNA after testing it following the most recent disease progression. --- T790M ---

6. T790M is allowed. --- T790M ---



HPO Nodes