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Report for Clinical Trial NCT04179890

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

UpSwinG: Real World Study on TKI Activity in Uncommon Mutations and Sequencing Giotrif®

Non-interventional, multi-country, multi-centre cohort study based on existing data from medical records (paper or electronic) or electronic health records of patients with advanced NSCLC harbouring EGFR mutations and treated with an EGFR-TKI

NCT04179890 Non-squamous, Non-Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Epidermal Growth Factor Tyrosine Kinase Inhibitor

Description: Up to 30 months
Type: Drug
Group Labels: 1

Uncommon mutation cohort

Name: Afatinib

Description: Up to 30 months
Type: Drug
Group Labels: 1

Sequencing cohort


Primary Outcomes

Description: assessed as the time from start of EGFR-TKI treatment until the end of treatment or death date by any cause.

Measure: Time on treatment with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor

Time: Up to 30 months

Secondary Outcomes

Measure: Rate of overall response

Time: Up to 30 months

Measure: Rate of overall survival

Time: Up to 30 months

Description: uncommon mutation cohort only

Measure: Time on treatment until failure of second-line (TTF2)

Time: Up to 30 months

Time Perspective: Retrospective

Cohort


There are 2 SNPs

SNPs


1 L858R

Sequencing cohort: 5. Patients with common EGFR mutations (Del19, L858R) 6. Patients were treated with afatinib (Gi(l)otrif®) in the first-line setting and for acquired T790M mutation with osimertinib in the second line; 7. Patients must have started osimertinib treatment at least 10 months prior to data entry. --- L858R ---


2 T790M

Sequencing cohort: 5. Patients with common EGFR mutations (Del19, L858R) 6. Patients were treated with afatinib (Gi(l)otrif®) in the first-line setting and for acquired T790M mutation with osimertinib in the second line; 7. Patients must have started osimertinib treatment at least 10 months prior to data entry. --- L858R --- --- T790M ---

For uncommon mutation cohort: Patients treated with osimertinib with no further uncommon mutation than acquired T790M Inclusion Criteria: 1. Adult patients 2. Diagnosed with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFRTKI) naïve advanced EGFR mutated non-small cell lung cancer (NSCLC), 3. treated for Epidermal Growth Factor Receptor (EGFR) mutated NSCLC within regular clinical practice. --- T790M ---

For uncommon mutation cohort: Patients treated with osimertinib with no further uncommon mutation than acquired T790M Non-squamous, Non-Small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- T790M ---



HPO Nodes


HPO: